Use of term reference infants in assessing the developmental outcome of extremely preterm infants : lessons learned in a multicenter study
© 2023. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply..
OBJECTIVE: Extremely preterm (EP) impairment rates are likely underestimated using the Bayley III norm-based thresholds scores and may be better assessed relative to concurrent healthy term reference (TR) infants born in the same hospital.
STUDY DESIGN: Blinded, certified examiners in the Neonatal Research Network (NRN) evaluated EP survivors and a sample of healthy TR infants recruited near the 2-year assessment age.
RESULTS: We assessed 1452 EP infants and 183 TR infants. TR-based thresholds showed higher overall EP impairment than Bayley norm-based thresholds (O.R. = 1.86; [95% CI 1.56-2.23], especially for severe impairment (36% vs. 24%; p ≤ 0.001). Difficulty recruiting TR patients at 2 years extended the study by 14 months and affected their demographics.
CONCLUSION: Impairment rates among EP infants appear to be substantially underestimated from Bayley III norms. These rates may be best assessed by comparison with healthy term infants followed with minimal attrition from birth in the same centers.
CLINICALTRIALS:.
GOV ID: Term Reference (under the Generic Database Study): NCT00063063.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:43 |
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| Enthalten in: |
Journal of perinatology : official journal of the California Perinatal Association - 43(2023), 11 vom: 29. Nov., Seite 1398-1405 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Green, Charles E [VerfasserIn] |
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| Links: |
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| Themen: |
Clinical Study |
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| Anmerkungen: |
Date Completed 06.11.2023 Date Revised 10.02.2024 published: Print-Electronic ClinicalTrials.gov: NCT00063063 Citation Status MEDLINE |
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| doi: |
10.1038/s41372-023-01729-x |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM360418473 |
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| 100 | 1 | |a Green, Charles E |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Use of term reference infants in assessing the developmental outcome of extremely preterm infants |b lessons learned in a multicenter study |
| 264 | 1 | |c 2023 | |
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| 500 | |a Date Completed 06.11.2023 | ||
| 500 | |a Date Revised 10.02.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT00063063 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply. | ||
| 520 | |a OBJECTIVE: Extremely preterm (EP) impairment rates are likely underestimated using the Bayley III norm-based thresholds scores and may be better assessed relative to concurrent healthy term reference (TR) infants born in the same hospital | ||
| 520 | |a STUDY DESIGN: Blinded, certified examiners in the Neonatal Research Network (NRN) evaluated EP survivors and a sample of healthy TR infants recruited near the 2-year assessment age | ||
| 520 | |a RESULTS: We assessed 1452 EP infants and 183 TR infants. TR-based thresholds showed higher overall EP impairment than Bayley norm-based thresholds (O.R. = 1.86; [95% CI 1.56-2.23], especially for severe impairment (36% vs. 24%; p ≤ 0.001). Difficulty recruiting TR patients at 2 years extended the study by 14 months and affected their demographics | ||
| 520 | |a CONCLUSION: Impairment rates among EP infants appear to be substantially underestimated from Bayley III norms. These rates may be best assessed by comparison with healthy term infants followed with minimal attrition from birth in the same centers | ||
| 520 | |a CLINICALTRIALS: | ||
| 520 | |a GOV ID: Term Reference (under the Generic Database Study): NCT00063063 | ||
| 650 | 4 | |a Clinical Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Research Support, N.I.H., Extramural | |
| 700 | 1 | |a Tyson, Jon E |e verfasserin |4 aut | |
| 700 | 1 | |a Heyne, Roy J |e verfasserin |4 aut | |
| 700 | 1 | |a Hintz, Susan R |e verfasserin |4 aut | |
| 700 | 1 | |a Vohr, Betty R |e verfasserin |4 aut | |
| 700 | 1 | |a Bann, Carla M |e verfasserin |4 aut | |
| 700 | 1 | |a Das, Abhik |e verfasserin |4 aut | |
| 700 | 1 | |a Bell, Edward F |e verfasserin |4 aut | |
| 700 | 1 | |a Debsareea, Sana Boral |e verfasserin |4 aut | |
| 700 | 1 | |a Stephens, Emily |e verfasserin |4 aut | |
| 700 | 1 | |a Gantz, Marie G |e verfasserin |4 aut | |
| 700 | 1 | |a Petrie Huitema, Carolyn M |e verfasserin |4 aut | |
| 700 | 1 | |a Johnson, Karen J |e verfasserin |4 aut | |
| 700 | 1 | |a Watterberg, Kristi L |e verfasserin |4 aut | |
| 700 | 1 | |a Mosquera, Ricardo |e verfasserin |4 aut | |
| 700 | 1 | |a Peralta-Carcelen, Myriam |e verfasserin |4 aut | |
| 700 | 1 | |a Wilson-Costello, Deanne E |e verfasserin |4 aut | |
| 700 | 1 | |a Colaizy, Tarah T |e verfasserin |4 aut | |
| 700 | 1 | |a Maitre, Nathalie L |e verfasserin |4 aut | |
| 700 | 1 | |a Merhar, Stephanie L |e verfasserin |4 aut | |
| 700 | 1 | |a Adams-Chapman, Ira |e verfasserin |4 aut | |
| 700 | 1 | |a Fuller, Janell |e verfasserin |4 aut | |
| 700 | 1 | |a Hartley-McAndrew, Michelle E |e verfasserin |4 aut | |
| 700 | 1 | |a Malcolm, William F |e verfasserin |4 aut | |
| 700 | 1 | |a Winter, Sarah |e verfasserin |4 aut | |
| 700 | 1 | |a Duncan, Andrea F |e verfasserin |4 aut | |
| 700 | 1 | |a Myer, Gary J |e verfasserin |4 aut | |
| 700 | 1 | |a Kicklighter, Stephen D |e verfasserin |4 aut | |
| 700 | 1 | |a Wyckoff, Myra H |e verfasserin |4 aut | |
| 700 | 1 | |a DeMauro, Sara B |e verfasserin |4 aut | |
| 700 | 1 | |a Hibbs, Anna Maria |e verfasserin |4 aut | |
| 700 | 1 | |a Stoll, Barbara J |e verfasserin |4 aut | |
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| 700 | 1 | |a Van Meurs, Krisa P |e verfasserin |4 aut | |
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| 700 | 1 | |a Cotten, C Michael |e verfasserin |4 aut | |
| 700 | 1 | |a D'Angio, Carl T |e verfasserin |4 aut | |
| 700 | 1 | |a Walsh, Michele C |e verfasserin |4 aut | |
| 700 | 0 | |a Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network |e verfasserin |4 aut | |
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