Ira Adams-Chapman1, Kristi L Watterberg2, Tracy L Nolen3, Shawn Hirsch3, Carol A Cole4, C Michael Cotten5, William Oh6, Brenda B Poindexter7,8, Kristin M Zaterka-Baxter3, Abhik Das9, Conra Backstrom Lacy2, Ann Marie Scorsone4, Andrea F Duncan10, Sara B DeMauro11, Ricki F Goldstein5, Tarah T Colaizy12, Deanne E Wilson-Costello13, Isabell B Purdy14, Susan R Hintz15, Roy J Heyne16, Gary J Myers4, Janell Fuller2, Stephanie Merhar7, Heidi M Harmon12,8, Myriam Peralta-Carcelen17, Howard W Kilbride18, Nathalie L Maitre19, Betty R Vohr6, Girija Natarajan20, Helen Mintz-Hittner21, Graham E Quinn22, David K Wallace23,24, Richard J Olson25, Faruk H Orge26, Irena Tsui27, Michael Gaynon28, Amy K Hutchinson29, Yu-Guang He30, Timothy W Winter31, Michael B Yang32, Kathryn M Haider24, Martin S Cogen33, Denise Hug34, Don L Bremer35, John P Donahue36, William R Lucas37, Dale L Phelps4, Rosemary D Higgins38,39. 1. Department of Pediatrics, Emory University School of Medicine and Children's Healthcare of Atlanta, Atlanta, GA, USA. 2. University of New Mexico Health Sciences Center, Albuquerque, NM, USA. 3. Social, Statistical and Environmental Sciences Unit, RTI International, Research Triangle Park, North Carolina, NC, USA. 4. University of Rochester School of Medicine and Dentistry, Rochester, NY, USA. 5. Department of Pediatrics, Duke University, Durham, NC, USA. 6. Department of Pediatrics, Women & Infants' Hospital, Brown University, Providence, RI, USA. 7. Department of Pediatrics, Cincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, OH, USA. 8. Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN, USA. 9. Social, Statistical and Environmental Sciences Unit, RTI International, Rockville, MD, USA. 10. Department of Pediatrics, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, TX, USA. 11. Department of Pediatrics, The Children's Hospital of Philadelphia and The University of Pennsylvania, Philadelphia, PA, USA. 12. Department of Pediatrics, University of Iowa, Iowa City, IA, USA. 13. Department of Pediatrics, Rainbow Babies & Children's Hospital, Case Western Reserve University, Cleveland, OH, USA. 14. Department of Pediatrics, University of California, Los Angeles, CA, USA. 15. Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto, CA, USA. 16. Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, USA. 17. Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL, USA. 18. Department of Pediatrics, Children's Mercy Hospital and University of Missouri Kansas City School of Medicine, Kansas City, MO, USA. 19. Department of Pediatrics, Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, OH, USA. 20. Department of Pediatrics, Wayne State University, Detroit, MI, USA. 21. Department of Ophthalmology and Visual Science, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, TX, USA. 22. Department of Ophthalmology, The Children's Hospital of Philadelphia and The University of Pennsylvania, Philadelphia, PA, USA. 23. Department of Ophthalmology, Duke University, Durham, NC, USA. 24. Department of Ophthalmology, Indiana University School of Medicine, Indianapolis, IN, USA. 25. Department of Ophthalmology and Visual Sciences, University of Iowa, Iowa City, IA, USA. 26. Department of Ophthalmology, Rainbow Babies & Children's Hospital, Case Western Reserve University, Cleveland, OH, USA. 27. Department of Ophthalmology, University of California, Los Angeles, CA, USA. 28. Department of Ophthalmology, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto, CA, USA. 29. Department of Ophthalmology, Emory University School of Medicine and Children's Healthcare of Atlanta, Atlanta, GA, USA. 30. Department of Ophthalmology, University of Texas Southwestern Medical Center, Dallas, TX, USA. 31. Division of Ophthalmology/Department of Surgery, University of New Mexico Health Sciences Center, Albuquerque, NM, USA. 32. Department of Ophthalmology, Cincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, OH, USA. 33. Department of Ophthalmology, University of Alabama at Birmingham, Birmingham, AL, USA. 34. Department of Ophthalmology, Children's Mercy Hospital and University of Missouri Kansas City School of Medicine, Kansas City, MO, USA. 35. Department of Ophthalmology, Nationwide Children's Hospital, Columbus, OH, USA. 36. Alpert Medical School of Brown University and Consulting Staff, Women & Infants Hospital of Rhode Island, Providence, RI, USA. 37. Department of Ophthalmology, Wayne State University, Detroit, MI, USA. 38. Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA. rhiggin@gmu.edu. 39. College of Health and Human Services, George Mason University, Fairfax, VA, USA. rhiggin@gmu.edu.
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.
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.