Development of Standards for the New Ballard Maturation Score

Completed

Conditions studied: Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Pregnancy

In brief

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.

Key facts

Study ID

NCT01203449

Run by

NICHD Neonatal Research Network

People needed

1090

Starts

1994-06-01

Expected to finish

1996-03-01

Last updated by the study team

2015-06-08

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• <28 weeks gestational age by best obstetrical estimate
• Availability of mother's prenatal records for review
• First prenatal visit occurred before 17 weeks' gestation
• Mother's menstrual history allowed calculation of GA at birth
• Mother reported the duration of her usual menstrual cycles as 21 to 35 days
• Mother had 3 consecutive normal menstrual cycles before the missed menstrual period identifying the index pregnancy
• Mother reported that she was certain within 4 days of the first day of the last menstrual period (as recorded at the time of the first prenatal visit)
• Mother denied use of birth control medication during the 3 months preceding the last menstrual period.

You may not qualify if…

• Inaccurate or unavailable menstrual histories

Where it is running

• Stanford University — Palo Alto, California, United States
• Yale University — New Haven, Connecticut, United States
• George Washington University — Washington D.C., District of Columbia, United States
• Emory University — Atlanta, Georgia, United States
• Indiana University — Indianapolis, Indiana, United States
• Wayne State University — Detroit, Michigan, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• Cincinnati Children's Medical Center — Cincinnati, Ohio, United States
• Case Western Reserve University, Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States
• University of Tennessee — Memphis, Tennessee, United States
• University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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