Neurodevelopmental outcome of preterm infants enrolled in myo-inositol randomized controlled trial

doi:10.1038/s41372-021-01018-5

Neurodevelopmental outcome of preterm infants enrolled in myo-inositol randomized controlled trial

Pediatrics

Research output: Contribution to journal › Article › peer-review

2 Scopus citations

Abstract

Objective: This study evaluates the 24-month follow-up for the NICHD Neonatal Research Network (NRN) Inositol for Retinopathy Trial. Study design: Bayley Scales of Infants Development-III and a standardized neurosensory examination were performed in infants enrolled in the main trial. Moderate/severe NDI was defined as BSID-III Cognitive or Motor composite score <85, moderate or severe cerebral palsy, blindness, or hearing loss that prevents communication despite amplification were assessed. Results: Primary outcome was determined for 605/638 (95%). The mean gestational age was 25.8 ± 1.3 weeks and mean birthweight was 805 ± 192 g. Treatment group did not affect the risk for the composite outcome of death or survival with moderate/severe NDI (60% vs 56%, p = 0.40). Conclusions: Treatment group did not affect the risk of death or survival with moderate/severe NDI. Despite early termination, this study represents the largest RCT of extremely preterm infants treated with myo-inositol with neurodevelopmental outcome data.

Original language	English
Pages (from-to)	2072-2087
Number of pages	16
Journal	Journal of Perinatology
Volume	41
Issue number	8
DOIs	https://doi.org/10.1038/s41372-021-01018-5
State	Published - Aug 2021

Bibliographical note

Funding Information:
Acknowledgements IA-C died after writing the manuscript. The study team appreciates her efforts in leading the follow-up study, data analysis and completion of the manuscript. She is a very special person and will be missed by all of the team. Mina Chung, MD, was the research ophthalmologist at the University of Rochester and conducted primary outcome examinations for study participants recruited at this center. Dr. Chung provided important contributions to the study concept and design and she performed ophthalmologic evaluations on the 63 infants enrolled at this site. Dr. Chung died prior to preparation of the final manuscript. The study team would like to extend a special acknowledgement of her efforts on this project. The National Institutes of Health and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) through the Neonatal Research Network, and the National Eye Institute (NEI) provided grant support for the Inositol Trial. While NICHD staff had input into the study design, conduct, analysis, and manuscript drafting, the comments and views of the authors do not necessarily represent the views of NICHD, NEI, the National Institutes of Health, the Department of Health and Human Services, or the U.S. Government. Participating NRN sites collected data and transmitted it to RTI International, the data coordinating center (DCC) for the network, which stored, managed and analyzed the data for this study. On behalf of the NRN, RTI International had full access to all of the data in the study, and with the NRN Center Principal Investigators, takes responsibility for the integrity of the data and accuracy of the data analysis. We are indebted to our medical and nursing colleagues and the infants and their parents who agreed to take part in this study. The following investigators, in addition to those listed as authors, participated in this study: NRN Steering Committee Chair: Richard A. Polin, MD, Division of Neonatology, College of Physicians and Surgeons, Columbia University, (2011-present). Alpert Medical School of Brown University and Women & Infants Hospital of Rhode Island (UG1 HD27904)—Abbot R. Laptook, MD; Martin Keszler, MD; Elisabeth C. McGowan, MD; Angelita M. Hensman, PhD RNC-NIC; Barbara Alksninis, PNP; Mary Lenore Keszler, MD; Andrea M. Knoll; Theresa M. Leach, MEd Emilee Little, RN BSN; Elisabeth C. McGowan, MD; Michael R. Muller, PharmD; Elisa Vieira, RN BSN; Victoria E. Watson, MS CAS. Case Western Reserve University, Rainbow Babies & Children’s Hospital (UG1 HD21364)—Michele C. Walsh, MD MS; Anna Maria Hibbs, MD MSCE; Nancy S. Newman, BA RN; Michael Banchy, RPH; Monika Bhola, MD; Jeffrey L. Blu-mer, MD; Allison H. Payne, MD MS; Bonnie S. Siner, RN; Elizabeth Ross, MS; Eileen K. Stork, MD; H. Gerry Taylor, PhD; Gulgun Yalcinkaya, MD; Arlene Zadell, RN. Children’s Mercy Hospital, University of Missouri Kansas City School of Medicine (UG1 HD68284)—William E. Truog, MD; Eugenia K. Pallotto, MD MSCE; Prabhu S. Parimi, MD; Cheri Gauldin, RN BSN CCRC; Lisa Gaetano, MSN RN; Anne M. Holmes, RN MSN MBA-HCM CCRC; Kathy Johnson RN, CCRC; Allison Knutson, BSN RNC-NIC. Cincinnati Children’s Hospital Medical Center, University of Cincinnati Medical Center, and Good Samaritan Hospital (UG1 HD27853, UL1 TR77)— Kurt Schibler, MD; Cathy Grisby, BSN CCRC; Patricia Cobb, MS; Teresa L. Gratton, PA; Kristin Kirker, CRC; Stacey Tepe, BS; Sandra Wuertz, RN-BSN CCRP CLC; Kimberly Yolton, PhD. Duke University School of Medicine, University Hospital, University of North Carolina, Duke Regional Hospital, and WakeMed Health and Hospitals (UG1 HD40492, UL1 TR1117)—Ronald N. Goldberg, MD; Joanne Finkle, RN JD; Kimberley A. Fisher, PhD FNP-BC IBCLC; William F. Malcolm, MD; Patricia L. Ashley, MD PHD; Deesha Mago-Shah, MD; Chi Dang-Hornik, PharmD BCPS; Sharon F. Freedman, MD; Kathryn E. Gustafson, PhD; Mary Miller-Bell, PharmD RPh; Sasapin Grace Prakalapakorn, MD MPH; Matthew M. Laughon, MD MPH; Carl L. Bose, MD; Janice Bernhardt, MS RN; Cindy Clark, RN; Diane D. Warner, MD MPH; TMO’S; Janice Wereszczak CPNP-AC/PC; Jennifer Talbert, MS RN; Stephen D. Kicklighter, MD; Sofia Aliaga, MD, MPH; Jeffery Board, MD; KRG; Jerry Magolan, MD; Linda Manor, RPh; Jan Niklas Ulrich, MD; Ginger Rhodes-Ryan, ARNP MSN NNP-BC; Donna White, BSN, RN-BC BSN; Alexandra Bentley, MD; Laura Edwards, MD. Emory University, Children’s Healthcare of Atlanta, Grady Memorial Hospital, and Emory University Hospital Midtown (UG1 HD27851, UL1 TR454)—David P. Carlton, MD; Barbara J. Stoll, MD; Ellen C. Hale, RN BS CCRC; Yvonne Loggins, RN; Diane I. Bottcher, RN MSN; Sheena L. Carter, PhD; Colleen Mackie, BS RT; Maureen Mulligan LaRossa, RN; Lynn C. Comerford, NNP; Gloria Smike, PNP MSN; Salathiel Kendrick-Allwood, MD; Angela Leon-Hernandez, MD. Eunice Kennedy Shriver National Institute of Child Health and Human Development—SWA. Indiana University, Riley Hospital for Children and Methodist Hospital at Indiana University Health (UG1 HD27856)—GMS; SG, NNP CCRC; DEH, RN CCRC; ACH; EHyn, RNC-NIC; L-AP; LS CCRC. McGovern Medical School at The University of Texas Health Science Center at Houston and Children’s Memorial Hermann Hospital (UG1 HD87229)—JET; KAK; AMK; ADu, RM, EA; JA-M, MSN APRN; SB, RCPhT; AGD; EE; FE-A, RPH; CG, RN BSN; KK; JJ, CPNP; PMJ; MLL, RN BSN; KM, RN; SCM, RN; GEM, RN; SME; HO; SR, RN; DS, RN; EKS, RN BSN; Vu Ta, PharmD; CW; SLW, MT (ASCP). Nationwide Children’s Hospital and The Ohio State University Wexner Medical Center (UG1 HD68278)—PJS; LDN; SRJ; AEG; PL; CAF; GEB; NAP; DLR; RPG; COJ. RTI International (U10 HD36790)—DW; MGG; CMB; JO’DA, BS; MMC, BS CCRP; JG, MPH CCRP; CMPH, MS CCRP; JWPII; AMV. Stanford University and Lucile Packard Children’s Hospital (UG1 HD27880, UL1 TR93)—KPVM; DKS; MBB, BS CCRC; SChi; MSP, RCP; BB, PsychD MSEd; MED; AMD, RN PNP PhD; BE; LCH; CEK; RL; HEW. University of Alabama at Birmingham Health System and Children’s Hospital of Alabama (UG1 HD34216)—WAC; NA; MVC, RN BSN MaEd; SSC, RN BSN; RJQ; BRD; AMA-B; FJB; KCJ, MSN CRNP; CSP; VAP, RN BSN; SW, MA OTR-L FAOTA. University of California—Los Angeles, Mattel Children’s Hospital, Santa Monica Hospital, Los Robles Hospital and Medical Center, and Olive View Medical Center (UG1 HD68270)—UD; MGarg; TC, MPH; RG, RN BSN. University of Iowa (UG1 HD53109, UL1 TR442)—EFB; JEB; KJJ, RN BSN; JRW, RN; CAG, RN; KMJ, BSPharm RPh; AM, BA CPhT; JLN, PharmD BCPS; SQL; AVD; DLE, RN CPNP MA; SAL; KRG; VPB. University of New Mexico Health Sciences Center (UG1 HD53089, UL1TR41)—RKO; SSB, MSN RNC; TD; MRH, RN BSN; CHH, MPH RN; EK, RN BSN; SJK; JL; NAM, RPh MBA. University of Oulu, and Oulu University Hospital, Oulu, Finland—MKH. University of Pennsylvania, Hospital of the University of Pennsylvania, Pennsylvania Hospital, and Children’s Hospital of Philadelphia (UG1 HD68244)—BS; HK; SA; ASC, BS RRT; TM, RN BSN CCRC; WVA; JCB; GB, MD MSCE; NC; SLD; MGerdes; HH; MDM; MR; KRJr; JS, RN BSN; SMY, RPh. University of Rochester Medical Center, Golisano Children’s Hospital, and the University of Buffalo Women’s and Children’s Hospital of Buffalo (UG1 HD68263, UL1 TR42)—CD’A; SL; AMR, MD MPH; SAB; MFC; PRC; RJ; RSR; AMT; AW, MS Ed; MGS, MAT; HW; JH; AH, LPN; MBo, RN NP; MH-M; WZ; OF; KY; JM, LMSW; CF; KB, BS; CO; PS, MPH. University of Texas Southwestern Medical Center, Parkland Health & Hospital System, and Children’s Medical Center Dallas (UG1 HD40689)—MHW; LPB; DMV, RNC-NIC; SSA, MS RN CPNP; CC; JC, RN; MMDL, BSN RN; FE, BSN RN; LG, PharmD RPh; LG, RN; AG; EH, PsyD PA-C; LEL, RN; HCL; AM, PharmD RPh; LP; CTB, MS CIMI; RW, RPh. Wayne State University, Hutzel Women’s Hospital and Children’s Hospital of Michigan (UG1 HD21385)—SS; BGS; RB, RN BSN; PA; MB; SCha; KC, RN BSN; MF; LAG; MEJ, RN BSN; ML-B, RPh; BP; EW, RN MSN. Data and Safety Monitoring Committee—CAG, MD, chair, University of Washington; MCA, MD, Johns Hopkins University School of Medicine; RJB, MD, University of Virginia Health System; Traci Clemons, PhD, The EMMES Corporation; MED’A, MD, Columbia Ob/Gyn Midtown; ADa (ex officio), PhD, RTI International; DEverett, MA (non-voting member), National Eye Institute; Ralph E. Kauffman, MD, University of Missouri-Kansas City, Medical Research Department at Children’s Mercy Hospital; Menachem Miodovnik, MD, Washington Hospital Center; TMO’S, MD MPH, Wake Forest University School of Medicine; Lois Smith, MD, Harvard University Children’s Hospital; Steven J. Weiner, MS, The George Washington University; Marian Willinger (ex officio), PhD, Eunice Kennedy Shriver National Institute of Child Health and Human Development. The BOOST Study ROP Credentialing site, www. boostnz.info/ROP/[boostnz.info, allowed NRN ophthalmologists to use their online system to certify their ROP training.

Publisher Copyright:
© 2021, This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply.

ASJC Scopus subject areas

Pediatrics, Perinatology, and Child Health
Obstetrics and Gynecology

Access to Document

10.1038/s41372-021-01018-5

Cite this

@article{3f55d7996b964335a2c75df1c7180c4a,

title = "Neurodevelopmental outcome of preterm infants enrolled in myo-inositol randomized controlled trial",

abstract = "Objective: This study evaluates the 24-month follow-up for the NICHD Neonatal Research Network (NRN) Inositol for Retinopathy Trial. Study design: Bayley Scales of Infants Development-III and a standardized neurosensory examination were performed in infants enrolled in the main trial. Moderate/severe NDI was defined as BSID-III Cognitive or Motor composite score <85, moderate or severe cerebral palsy, blindness, or hearing loss that prevents communication despite amplification were assessed. Results: Primary outcome was determined for 605/638 (95%). The mean gestational age was 25.8 ± 1.3 weeks and mean birthweight was 805 ± 192 g. Treatment group did not affect the risk for the composite outcome of death or survival with moderate/severe NDI (60% vs 56%, p = 0.40). Conclusions: Treatment group did not affect the risk of death or survival with moderate/severe NDI. Despite early termination, this study represents the largest RCT of extremely preterm infants treated with myo-inositol with neurodevelopmental outcome data.",

author = "Ira Adams-Chapman and Watterberg, {Kristi L.} and Nolen, {Tracy L.} and Shawn Hirsch and Cole, {Carol A.} and Cotten, {C. Michael} and William Oh and Poindexter, {Brenda B.} and Zaterka-Baxter, {Kristin M.} and Abhik Das and Lacy, {Conra Backstrom} and Scorsone, {Ann Marie} and Duncan, {Andrea F.} and DeMauro, {Sara B.} and Goldstein, {Ricki F.} and Colaizy, {Tarah T.} and Wilson-Costello, {Deanne E.} and Purdy, {Isabell B.} and Hintz, {Susan R.} and Heyne, {Roy J.} and Myers, {Gary J.} and Janell Fuller and Stephanie Merhar and Harmon, {Heidi M.} and Myriam Peralta-Carcelen and Kilbride, {Howard W.} and Maitre, {Nathalie L.} and Vohr, {Betty R.} and Girija Natarajan and Helen Mintz-Hittner and Quinn, {Graham E.} and Wallace, {David K.} and Olson, {Richard J.} and Orge, {Faruk H.} and Irena Tsui and Michael Gaynon and Hutchinson, {Amy K.} and He, {Yu Guang} and Winter, {Timothy W.} and Yang, {Michael B.} and Haider, {Kathryn M.} and Cogen, {Martin S.} and Denise Hug and Bremer, {Don L.} and Donahue, {John P.} and Lucas, {William R.} and Phelps, {Dale L.} and Higgins, {Rosemary D.} and Archer, {Stephanie Wilson} and Sokol, {Gregory M.}",

note = "Funding Information: Acknowledgements IA-C died after writing the manuscript. The study team appreciates her efforts in leading the follow-up study, data analysis and completion of the manuscript. She is a very special person and will be missed by all of the team. Mina Chung, MD, was the research ophthalmologist at the University of Rochester and conducted primary outcome examinations for study participants recruited at this center. Dr. Chung provided important contributions to the study concept and design and she performed ophthalmologic evaluations on the 63 infants enrolled at this site. Dr. Chung died prior to preparation of the final manuscript. The study team would like to extend a special acknowledgement of her efforts on this project. The National Institutes of Health and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) through the Neonatal Research Network, and the National Eye Institute (NEI) provided grant support for the Inositol Trial. While NICHD staff had input into the study design, conduct, analysis, and manuscript drafting, the comments and views of the authors do not necessarily represent the views of NICHD, NEI, the National Institutes of Health, the Department of Health and Human Services, or the U.S. Government. Participating NRN sites collected data and transmitted it to RTI International, the data coordinating center (DCC) for the network, which stored, managed and analyzed the data for this study. On behalf of the NRN, RTI International had full access to all of the data in the study, and with the NRN Center Principal Investigators, takes responsibility for the integrity of the data and accuracy of the data analysis. We are indebted to our medical and nursing colleagues and the infants and their parents who agreed to take part in this study. The following investigators, in addition to those listed as authors, participated in this study: NRN Steering Committee Chair: Richard A. Polin, MD, Division of Neonatology, College of Physicians and Surgeons, Columbia University, (2011-present). Alpert Medical School of Brown University and Women & Infants Hospital of Rhode Island (UG1 HD27904)—Abbot R. Laptook, MD; Martin Keszler, MD; Elisabeth C. McGowan, MD; Angelita M. Hensman, PhD RNC-NIC; Barbara Alksninis, PNP; Mary Lenore Keszler, MD; Andrea M. Knoll; Theresa M. Leach, MEd Emilee Little, RN BSN; Elisabeth C. McGowan, MD; Michael R. Muller, PharmD; Elisa Vieira, RN BSN; Victoria E. Watson, MS CAS. Case Western Reserve University, Rainbow Babies & Children{\textquoteright}s Hospital (UG1 HD21364)—Michele C. Walsh, MD MS; Anna Maria Hibbs, MD MSCE; Nancy S. Newman, BA RN; Michael Banchy, RPH; Monika Bhola, MD; Jeffrey L. Blu-mer, MD; Allison H. Payne, MD MS; Bonnie S. Siner, RN; Elizabeth Ross, MS; Eileen K. Stork, MD; H. Gerry Taylor, PhD; Gulgun Yalcinkaya, MD; Arlene Zadell, RN. Children{\textquoteright}s Mercy Hospital, University of Missouri Kansas City School of Medicine (UG1 HD68284)—William E. Truog, MD; Eugenia K. Pallotto, MD MSCE; Prabhu S. Parimi, MD; Cheri Gauldin, RN BSN CCRC; Lisa Gaetano, MSN RN; Anne M. Holmes, RN MSN MBA-HCM CCRC; Kathy Johnson RN, CCRC; Allison Knutson, BSN RNC-NIC. Cincinnati Children{\textquoteright}s Hospital Medical Center, University of Cincinnati Medical Center, and Good Samaritan Hospital (UG1 HD27853, UL1 TR77)— Kurt Schibler, MD; Cathy Grisby, BSN CCRC; Patricia Cobb, MS; Teresa L. Gratton, PA; Kristin Kirker, CRC; Stacey Tepe, BS; Sandra Wuertz, RN-BSN CCRP CLC; Kimberly Yolton, PhD. Duke University School of Medicine, University Hospital, University of North Carolina, Duke Regional Hospital, and WakeMed Health and Hospitals (UG1 HD40492, UL1 TR1117)—Ronald N. Goldberg, MD; Joanne Finkle, RN JD; Kimberley A. Fisher, PhD FNP-BC IBCLC; William F. Malcolm, MD; Patricia L. Ashley, MD PHD; Deesha Mago-Shah, MD; Chi Dang-Hornik, PharmD BCPS; Sharon F. Freedman, MD; Kathryn E. Gustafson, PhD; Mary Miller-Bell, PharmD RPh; Sasapin Grace Prakalapakorn, MD MPH; Matthew M. Laughon, MD MPH; Carl L. Bose, MD; Janice Bernhardt, MS RN; Cindy Clark, RN; Diane D. Warner, MD MPH; TMO{\textquoteright}S; Janice Wereszczak CPNP-AC/PC; Jennifer Talbert, MS RN; Stephen D. Kicklighter, MD; Sofia Aliaga, MD, MPH; Jeffery Board, MD; KRG; Jerry Magolan, MD; Linda Manor, RPh; Jan Niklas Ulrich, MD; Ginger Rhodes-Ryan, ARNP MSN NNP-BC; Donna White, BSN, RN-BC BSN; Alexandra Bentley, MD; Laura Edwards, MD. Emory University, Children{\textquoteright}s Healthcare of Atlanta, Grady Memorial Hospital, and Emory University Hospital Midtown (UG1 HD27851, UL1 TR454)—David P. Carlton, MD; Barbara J. Stoll, MD; Ellen C. Hale, RN BS CCRC; Yvonne Loggins, RN; Diane I. Bottcher, RN MSN; Sheena L. Carter, PhD; Colleen Mackie, BS RT; Maureen Mulligan LaRossa, RN; Lynn C. Comerford, NNP; Gloria Smike, PNP MSN; Salathiel Kendrick-Allwood, MD; Angela Leon-Hernandez, MD. Eunice Kennedy Shriver National Institute of Child Health and Human Development—SWA. Indiana University, Riley Hospital for Children and Methodist Hospital at Indiana University Health (UG1 HD27856)—GMS; SG, NNP CCRC; DEH, RN CCRC; ACH; EHyn, RNC-NIC; L-AP; LS CCRC. McGovern Medical School at The University of Texas Health Science Center at Houston and Children{\textquoteright}s Memorial Hermann Hospital (UG1 HD87229)—JET; KAK; AMK; ADu, RM, EA; JA-M, MSN APRN; SB, RCPhT; AGD; EE; FE-A, RPH; CG, RN BSN; KK; JJ, CPNP; PMJ; MLL, RN BSN; KM, RN; SCM, RN; GEM, RN; SME; HO; SR, RN; DS, RN; EKS, RN BSN; Vu Ta, PharmD; CW; SLW, MT (ASCP). Nationwide Children{\textquoteright}s Hospital and The Ohio State University Wexner Medical Center (UG1 HD68278)—PJS; LDN; SRJ; AEG; PL; CAF; GEB; NAP; DLR; RPG; COJ. RTI International (U10 HD36790)—DW; MGG; CMB; JO{\textquoteright}DA, BS; MMC, BS CCRP; JG, MPH CCRP; CMPH, MS CCRP; JWPII; AMV. Stanford University and Lucile Packard Children{\textquoteright}s Hospital (UG1 HD27880, UL1 TR93)—KPVM; DKS; MBB, BS CCRC; SChi; MSP, RCP; BB, PsychD MSEd; MED; AMD, RN PNP PhD; BE; LCH; CEK; RL; HEW. University of Alabama at Birmingham Health System and Children{\textquoteright}s Hospital of Alabama (UG1 HD34216)—WAC; NA; MVC, RN BSN MaEd; SSC, RN BSN; RJQ; BRD; AMA-B; FJB; KCJ, MSN CRNP; CSP; VAP, RN BSN; SW, MA OTR-L FAOTA. University of California—Los Angeles, Mattel Children{\textquoteright}s Hospital, Santa Monica Hospital, Los Robles Hospital and Medical Center, and Olive View Medical Center (UG1 HD68270)—UD; MGarg; TC, MPH; RG, RN BSN. University of Iowa (UG1 HD53109, UL1 TR442)—EFB; JEB; KJJ, RN BSN; JRW, RN; CAG, RN; KMJ, BSPharm RPh; AM, BA CPhT; JLN, PharmD BCPS; SQL; AVD; DLE, RN CPNP MA; SAL; KRG; VPB. University of New Mexico Health Sciences Center (UG1 HD53089, UL1TR41)—RKO; SSB, MSN RNC; TD; MRH, RN BSN; CHH, MPH RN; EK, RN BSN; SJK; JL; NAM, RPh MBA. University of Oulu, and Oulu University Hospital, Oulu, Finland—MKH. University of Pennsylvania, Hospital of the University of Pennsylvania, Pennsylvania Hospital, and Children{\textquoteright}s Hospital of Philadelphia (UG1 HD68244)—BS; HK; SA; ASC, BS RRT; TM, RN BSN CCRC; WVA; JCB; GB, MD MSCE; NC; SLD; MGerdes; HH; MDM; MR; KRJr; JS, RN BSN; SMY, RPh. University of Rochester Medical Center, Golisano Children{\textquoteright}s Hospital, and the University of Buffalo Women{\textquoteright}s and Children{\textquoteright}s Hospital of Buffalo (UG1 HD68263, UL1 TR42)—CD{\textquoteright}A; SL; AMR, MD MPH; SAB; MFC; PRC; RJ; RSR; AMT; AW, MS Ed; MGS, MAT; HW; JH; AH, LPN; MBo, RN NP; MH-M; WZ; OF; KY; JM, LMSW; CF; KB, BS; CO; PS, MPH. University of Texas Southwestern Medical Center, Parkland Health & Hospital System, and Children{\textquoteright}s Medical Center Dallas (UG1 HD40689)—MHW; LPB; DMV, RNC-NIC; SSA, MS RN CPNP; CC; JC, RN; MMDL, BSN RN; FE, BSN RN; LG, PharmD RPh; LG, RN; AG; EH, PsyD PA-C; LEL, RN; HCL; AM, PharmD RPh; LP; CTB, MS CIMI; RW, RPh. Wayne State University, Hutzel Women{\textquoteright}s Hospital and Children{\textquoteright}s Hospital of Michigan (UG1 HD21385)—SS; BGS; RB, RN BSN; PA; MB; SCha; KC, RN BSN; MF; LAG; MEJ, RN BSN; ML-B, RPh; BP; EW, RN MSN. Data and Safety Monitoring Committee—CAG, MD, chair, University of Washington; MCA, MD, Johns Hopkins University School of Medicine; RJB, MD, University of Virginia Health System; Traci Clemons, PhD, The EMMES Corporation; MED{\textquoteright}A, MD, Columbia Ob/Gyn Midtown; ADa (ex officio), PhD, RTI International; DEverett, MA (non-voting member), National Eye Institute; Ralph E. Kauffman, MD, University of Missouri-Kansas City, Medical Research Department at Children{\textquoteright}s Mercy Hospital; Menachem Miodovnik, MD, Washington Hospital Center; TMO{\textquoteright}S, MD MPH, Wake Forest University School of Medicine; Lois Smith, MD, Harvard University Children{\textquoteright}s Hospital; Steven J. Weiner, MS, The George Washington University; Marian Willinger (ex officio), PhD, Eunice Kennedy Shriver National Institute of Child Health and Human Development. The BOOST Study ROP Credentialing site, www. boostnz.info/ROP/[boostnz.info, allowed NRN ophthalmologists to use their online system to certify their ROP training. Publisher Copyright: {\textcopyright} 2021, This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply.",

year = "2021",

month = aug,

doi = "10.1038/s41372-021-01018-5",

language = "English",

volume = "41",

pages = "2072--2087",

number = "8",

}

TY - JOUR

T1 - Neurodevelopmental outcome of preterm infants enrolled in myo-inositol randomized controlled trial

AU - Adams-Chapman, Ira

AU - Watterberg, Kristi L.

AU - Nolen, Tracy L.

AU - Hirsch, Shawn

AU - Cole, Carol A.

AU - Cotten, C. Michael

AU - Oh, William

AU - Poindexter, Brenda B.

AU - Zaterka-Baxter, Kristin M.

AU - Das, Abhik

AU - Lacy, Conra Backstrom

AU - Scorsone, Ann Marie

AU - Duncan, Andrea F.

AU - DeMauro, Sara B.

AU - Goldstein, Ricki F.

AU - Colaizy, Tarah T.

AU - Wilson-Costello, Deanne E.

AU - Purdy, Isabell B.

AU - Hintz, Susan R.

AU - Heyne, Roy J.

AU - Myers, Gary J.

AU - Fuller, Janell

AU - Merhar, Stephanie

AU - Harmon, Heidi M.

AU - Peralta-Carcelen, Myriam

AU - Kilbride, Howard W.

AU - Maitre, Nathalie L.

AU - Vohr, Betty R.

AU - Natarajan, Girija

AU - Mintz-Hittner, Helen

AU - Quinn, Graham E.

AU - Wallace, David K.

AU - Olson, Richard J.

AU - Orge, Faruk H.

AU - Tsui, Irena

AU - Gaynon, Michael

AU - Hutchinson, Amy K.

AU - He, Yu Guang

AU - Winter, Timothy W.

AU - Yang, Michael B.

AU - Haider, Kathryn M.

AU - Cogen, Martin S.

AU - Hug, Denise

AU - Bremer, Don L.

AU - Donahue, John P.

AU - Lucas, William R.

AU - Phelps, Dale L.

AU - Higgins, Rosemary D.

AU - Archer, Stephanie Wilson

AU - Sokol, Gregory M.

N1 - Funding Information: Acknowledgements IA-C died after writing the manuscript. The study team appreciates her efforts in leading the follow-up study, data analysis and completion of the manuscript. She is a very special person and will be missed by all of the team. Mina Chung, MD, was the research ophthalmologist at the University of Rochester and conducted primary outcome examinations for study participants recruited at this center. Dr. Chung provided important contributions to the study concept and design and she performed ophthalmologic evaluations on the 63 infants enrolled at this site. Dr. Chung died prior to preparation of the final manuscript. The study team would like to extend a special acknowledgement of her efforts on this project. The National Institutes of Health and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) through the Neonatal Research Network, and the National Eye Institute (NEI) provided grant support for the Inositol Trial. While NICHD staff had input into the study design, conduct, analysis, and manuscript drafting, the comments and views of the authors do not necessarily represent the views of NICHD, NEI, the National Institutes of Health, the Department of Health and Human Services, or the U.S. Government. Participating NRN sites collected data and transmitted it to RTI International, the data coordinating center (DCC) for the network, which stored, managed and analyzed the data for this study. On behalf of the NRN, RTI International had full access to all of the data in the study, and with the NRN Center Principal Investigators, takes responsibility for the integrity of the data and accuracy of the data analysis. We are indebted to our medical and nursing colleagues and the infants and their parents who agreed to take part in this study. The following investigators, in addition to those listed as authors, participated in this study: NRN Steering Committee Chair: Richard A. Polin, MD, Division of Neonatology, College of Physicians and Surgeons, Columbia University, (2011-present). Alpert Medical School of Brown University and Women & Infants Hospital of Rhode Island (UG1 HD27904)—Abbot R. Laptook, MD; Martin Keszler, MD; Elisabeth C. McGowan, MD; Angelita M. Hensman, PhD RNC-NIC; Barbara Alksninis, PNP; Mary Lenore Keszler, MD; Andrea M. Knoll; Theresa M. Leach, MEd Emilee Little, RN BSN; Elisabeth C. McGowan, MD; Michael R. Muller, PharmD; Elisa Vieira, RN BSN; Victoria E. Watson, MS CAS. Case Western Reserve University, Rainbow Babies & Children’s Hospital (UG1 HD21364)—Michele C. Walsh, MD MS; Anna Maria Hibbs, MD MSCE; Nancy S. Newman, BA RN; Michael Banchy, RPH; Monika Bhola, MD; Jeffrey L. Blu-mer, MD; Allison H. Payne, MD MS; Bonnie S. Siner, RN; Elizabeth Ross, MS; Eileen K. Stork, MD; H. Gerry Taylor, PhD; Gulgun Yalcinkaya, MD; Arlene Zadell, RN. Children’s Mercy Hospital, University of Missouri Kansas City School of Medicine (UG1 HD68284)—William E. Truog, MD; Eugenia K. Pallotto, MD MSCE; Prabhu S. Parimi, MD; Cheri Gauldin, RN BSN CCRC; Lisa Gaetano, MSN RN; Anne M. Holmes, RN MSN MBA-HCM CCRC; Kathy Johnson RN, CCRC; Allison Knutson, BSN RNC-NIC. Cincinnati Children’s Hospital Medical Center, University of Cincinnati Medical Center, and Good Samaritan Hospital (UG1 HD27853, UL1 TR77)— Kurt Schibler, MD; Cathy Grisby, BSN CCRC; Patricia Cobb, MS; Teresa L. Gratton, PA; Kristin Kirker, CRC; Stacey Tepe, BS; Sandra Wuertz, RN-BSN CCRP CLC; Kimberly Yolton, PhD. Duke University School of Medicine, University Hospital, University of North Carolina, Duke Regional Hospital, and WakeMed Health and Hospitals (UG1 HD40492, UL1 TR1117)—Ronald N. Goldberg, MD; Joanne Finkle, RN JD; Kimberley A. Fisher, PhD FNP-BC IBCLC; William F. Malcolm, MD; Patricia L. Ashley, MD PHD; Deesha Mago-Shah, MD; Chi Dang-Hornik, PharmD BCPS; Sharon F. Freedman, MD; Kathryn E. Gustafson, PhD; Mary Miller-Bell, PharmD RPh; Sasapin Grace Prakalapakorn, MD MPH; Matthew M. Laughon, MD MPH; Carl L. Bose, MD; Janice Bernhardt, MS RN; Cindy Clark, RN; Diane D. Warner, MD MPH; TMO’S; Janice Wereszczak CPNP-AC/PC; Jennifer Talbert, MS RN; Stephen D. Kicklighter, MD; Sofia Aliaga, MD, MPH; Jeffery Board, MD; KRG; Jerry Magolan, MD; Linda Manor, RPh; Jan Niklas Ulrich, MD; Ginger Rhodes-Ryan, ARNP MSN NNP-BC; Donna White, BSN, RN-BC BSN; Alexandra Bentley, MD; Laura Edwards, MD. Emory University, Children’s Healthcare of Atlanta, Grady Memorial Hospital, and Emory University Hospital Midtown (UG1 HD27851, UL1 TR454)—David P. Carlton, MD; Barbara J. Stoll, MD; Ellen C. Hale, RN BS CCRC; Yvonne Loggins, RN; Diane I. Bottcher, RN MSN; Sheena L. Carter, PhD; Colleen Mackie, BS RT; Maureen Mulligan LaRossa, RN; Lynn C. Comerford, NNP; Gloria Smike, PNP MSN; Salathiel Kendrick-Allwood, MD; Angela Leon-Hernandez, MD. Eunice Kennedy Shriver National Institute of Child Health and Human Development—SWA. Indiana University, Riley Hospital for Children and Methodist Hospital at Indiana University Health (UG1 HD27856)—GMS; SG, NNP CCRC; DEH, RN CCRC; ACH; EHyn, RNC-NIC; L-AP; LS CCRC. McGovern Medical School at The University of Texas Health Science Center at Houston and Children’s Memorial Hermann Hospital (UG1 HD87229)—JET; KAK; AMK; ADu, RM, EA; JA-M, MSN APRN; SB, RCPhT; AGD; EE; FE-A, RPH; CG, RN BSN; KK; JJ, CPNP; PMJ; MLL, RN BSN; KM, RN; SCM, RN; GEM, RN; SME; HO; SR, RN; DS, RN; EKS, RN BSN; Vu Ta, PharmD; CW; SLW, MT (ASCP). Nationwide Children’s Hospital and The Ohio State University Wexner Medical Center (UG1 HD68278)—PJS; LDN; SRJ; AEG; PL; CAF; GEB; NAP; DLR; RPG; COJ. RTI International (U10 HD36790)—DW; MGG; CMB; JO’DA, BS; MMC, BS CCRP; JG, MPH CCRP; CMPH, MS CCRP; JWPII; AMV. Stanford University and Lucile Packard Children’s Hospital (UG1 HD27880, UL1 TR93)—KPVM; DKS; MBB, BS CCRC; SChi; MSP, RCP; BB, PsychD MSEd; MED; AMD, RN PNP PhD; BE; LCH; CEK; RL; HEW. University of Alabama at Birmingham Health System and Children’s Hospital of Alabama (UG1 HD34216)—WAC; NA; MVC, RN BSN MaEd; SSC, RN BSN; RJQ; BRD; AMA-B; FJB; KCJ, MSN CRNP; CSP; VAP, RN BSN; SW, MA OTR-L FAOTA. University of California—Los Angeles, Mattel Children’s Hospital, Santa Monica Hospital, Los Robles Hospital and Medical Center, and Olive View Medical Center (UG1 HD68270)—UD; MGarg; TC, MPH; RG, RN BSN. University of Iowa (UG1 HD53109, UL1 TR442)—EFB; JEB; KJJ, RN BSN; JRW, RN; CAG, RN; KMJ, BSPharm RPh; AM, BA CPhT; JLN, PharmD BCPS; SQL; AVD; DLE, RN CPNP MA; SAL; KRG; VPB. University of New Mexico Health Sciences Center (UG1 HD53089, UL1TR41)—RKO; SSB, MSN RNC; TD; MRH, RN BSN; CHH, MPH RN; EK, RN BSN; SJK; JL; NAM, RPh MBA. University of Oulu, and Oulu University Hospital, Oulu, Finland—MKH. University of Pennsylvania, Hospital of the University of Pennsylvania, Pennsylvania Hospital, and Children’s Hospital of Philadelphia (UG1 HD68244)—BS; HK; SA; ASC, BS RRT; TM, RN BSN CCRC; WVA; JCB; GB, MD MSCE; NC; SLD; MGerdes; HH; MDM; MR; KRJr; JS, RN BSN; SMY, RPh. University of Rochester Medical Center, Golisano Children’s Hospital, and the University of Buffalo Women’s and Children’s Hospital of Buffalo (UG1 HD68263, UL1 TR42)—CD’A; SL; AMR, MD MPH; SAB; MFC; PRC; RJ; RSR; AMT; AW, MS Ed; MGS, MAT; HW; JH; AH, LPN; MBo, RN NP; MH-M; WZ; OF; KY; JM, LMSW; CF; KB, BS; CO; PS, MPH. University of Texas Southwestern Medical Center, Parkland Health & Hospital System, and Children’s Medical Center Dallas (UG1 HD40689)—MHW; LPB; DMV, RNC-NIC; SSA, MS RN CPNP; CC; JC, RN; MMDL, BSN RN; FE, BSN RN; LG, PharmD RPh; LG, RN; AG; EH, PsyD PA-C; LEL, RN; HCL; AM, PharmD RPh; LP; CTB, MS CIMI; RW, RPh. Wayne State University, Hutzel Women’s Hospital and Children’s Hospital of Michigan (UG1 HD21385)—SS; BGS; RB, RN BSN; PA; MB; SCha; KC, RN BSN; MF; LAG; MEJ, RN BSN; ML-B, RPh; BP; EW, RN MSN. Data and Safety Monitoring Committee—CAG, MD, chair, University of Washington; MCA, MD, Johns Hopkins University School of Medicine; RJB, MD, University of Virginia Health System; Traci Clemons, PhD, The EMMES Corporation; MED’A, MD, Columbia Ob/Gyn Midtown; ADa (ex officio), PhD, RTI International; DEverett, MA (non-voting member), National Eye Institute; Ralph E. Kauffman, MD, University of Missouri-Kansas City, Medical Research Department at Children’s Mercy Hospital; Menachem Miodovnik, MD, Washington Hospital Center; TMO’S, MD MPH, Wake Forest University School of Medicine; Lois Smith, MD, Harvard University Children’s Hospital; Steven J. Weiner, MS, The George Washington University; Marian Willinger (ex officio), PhD, Eunice Kennedy Shriver National Institute of Child Health and Human Development. The BOOST Study ROP Credentialing site, www. boostnz.info/ROP/[boostnz.info, allowed NRN ophthalmologists to use their online system to certify their ROP training. Publisher Copyright: © 2021, This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply.

PY - 2021/8

Y1 - 2021/8

N2 - Objective: This study evaluates the 24-month follow-up for the NICHD Neonatal Research Network (NRN) Inositol for Retinopathy Trial. Study design: Bayley Scales of Infants Development-III and a standardized neurosensory examination were performed in infants enrolled in the main trial. Moderate/severe NDI was defined as BSID-III Cognitive or Motor composite score <85, moderate or severe cerebral palsy, blindness, or hearing loss that prevents communication despite amplification were assessed. Results: Primary outcome was determined for 605/638 (95%). The mean gestational age was 25.8 ± 1.3 weeks and mean birthweight was 805 ± 192 g. Treatment group did not affect the risk for the composite outcome of death or survival with moderate/severe NDI (60% vs 56%, p = 0.40). Conclusions: Treatment group did not affect the risk of death or survival with moderate/severe NDI. Despite early termination, this study represents the largest RCT of extremely preterm infants treated with myo-inositol with neurodevelopmental outcome data.

AB - Objective: This study evaluates the 24-month follow-up for the NICHD Neonatal Research Network (NRN) Inositol for Retinopathy Trial. Study design: Bayley Scales of Infants Development-III and a standardized neurosensory examination were performed in infants enrolled in the main trial. Moderate/severe NDI was defined as BSID-III Cognitive or Motor composite score <85, moderate or severe cerebral palsy, blindness, or hearing loss that prevents communication despite amplification were assessed. Results: Primary outcome was determined for 605/638 (95%). The mean gestational age was 25.8 ± 1.3 weeks and mean birthweight was 805 ± 192 g. Treatment group did not affect the risk for the composite outcome of death or survival with moderate/severe NDI (60% vs 56%, p = 0.40). Conclusions: Treatment group did not affect the risk of death or survival with moderate/severe NDI. Despite early termination, this study represents the largest RCT of extremely preterm infants treated with myo-inositol with neurodevelopmental outcome data.

UR - http://www.scopus.com/inward/record.url?scp=85103247984&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85103247984&partnerID=8YFLogxK

U2 - 10.1038/s41372-021-01018-5

DO - 10.1038/s41372-021-01018-5

M3 - Article

C2 - 33758387

AN - SCOPUS:85103247984

SN - 0743-8346

VL - 41

SP - 2072

EP - 2087

JO - Journal of Perinatology

JF - Journal of Perinatology

IS - 8

ER -

Neurodevelopmental outcome of preterm infants enrolled in myo-inositol randomized controlled trial

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