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Clinical Trial Summary

The primary purpose of this study was to evaluate the accuracy of gestational age (GA) estimates by using the New Ballard Score (NBS) in newborns 24 to 27 weeks GA with accurate obstetric estimates of GA. Secondary purposes were: (1) to compare the accuracy of GA estimates derived from the NBS, the original Ballard score, and the physical items of the original Ballard score and (2) to compare these measures of GA and best obstetric estimates of GA as predictors of survival, morbidity, and hospital stay among infants <28 weeks' gestation and among very low birth weight infants in general.


Clinical Trial Description

The Ballard maturational assessment is commonly used to estimate gestational age (GA) when the menstrual history and other obstetrical estimates of GA are uncertain. The original Ballard Score and the New Ballard Score are based on the assumption that the fetal skin, subcutaneous tissues, and neuromuscular system mature at predictable rates.

Because of variation in maturation rates among healthy fetuses or abnormalities of fetal development, fetal maturation can vary at a given GA. For very premature infants, small differences in GA result in large differences in outcome and may even determine whether intensive care is given.

The primary purpose of this study was to evaluate the accuracy of GA estimates by using the NBS in newborns 24 to 27 weeks GA with accurate obstetric estimates of GA. Secondary purposes were: (1) to compare the accuracy of GA estimates derived from the NBS, the original Ballard score, and the physical items of the original Ballard score and (2) to compare these measures of GA and best obstetric estimates of GA as predictors of survival, morbidity, and hospital stay among infants <28 weeks' gestation and among very low birth weight infants in general.

For this study, eligible infants included those with birth weights of 401-1500g born in the National Institute of Child and Human Development (NICHD) Neonatal Research Network (NRN). Before 48 hours of age, enrolled infants were examined using the New Ballard Score by trained and certified research nurses masked to obstetric estimates of gestational age. A best obstetrical estimate of GA, used for screening of potentially eligible infants, was determined from the last menstrual period, obstetrical measures, and ultrasound findings recorded on the labor and delivery records. ;


Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT01203449
Study type Observational
Source NICHD Neonatal Research Network
Contact
Status Completed
Phase N/A
Start date June 1994
Completion date March 1996

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