Development of Standards for the New Ballard Maturation Score

Sponsor

NICHD Neonatal Research Network (Other)

Overall Status

Completed

CT.gov ID

NCT01203449

Collaborator

National Center for Research Resources (NCRR) (NIH)

1,090

Enrollment

Locations

Duration (Months)

99.1

Patients Per Site

4.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature Pregnancy

Detailed 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

Study Type:

Observational

Actual Enrollment :

1090 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Development of Standards for the New Ballard Maturation Score

Study Start Date :

Jun 1, 1994

Actual Primary Completion Date :

Mar 1, 1996

Actual Study Completion Date :

Mar 1, 1996

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 48 Hours

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

<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.

Exclusion Criteria:

Inaccurate or unavailable menstrual histories

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Palo Alto	California	United States	94304
2	Yale University	New Haven	Connecticut	United States	06504
3	George Washington University	Washington	District of Columbia	United States	20052
4	Emory University	Atlanta	Georgia	United States	30303
5	Indiana University	Indianapolis	Indiana	United States	46202
6	Wayne State University	Detroit	Michigan	United States	48201
7	University of New Mexico	Albuquerque	New Mexico	United States	87131
8	Cincinnati Children's Medical Center	Cincinnati	Ohio	United States	45267
9	Case Western Reserve University, Rainbow Babies and Children's Hospital	Cleveland	Ohio	United States	44106
10	University of Tennessee	Memphis	Tennessee	United States	38163
11	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas	United States	75235

Sponsors and Collaborators

NICHD Neonatal Research Network
National Center for Research Resources (NCRR)

Investigators

Study Director: Edward F. Donovan, MD, Children's Hospital Medical Center, Cincinnati
Principal Investigator: Richard A. Ehrenkranz, MD, Yale University
Principal Investigator: Seetha Shankaran, MD, Wayne State University
Principal Investigator: David K. Stevenson, MD, Stanford University
Principal Investigator: Raymond Bain, PhD, George Washington University
Principal Investigator: Avroy A. Fanaroff, MD, Case Western Reserve University
Principal Investigator: Sheldon B. Korones, MD, University of Tennessee at Memphis
Principal Investigator: Barbara J. Stoll, MD, Emory University
Principal Investigator: Jon E. Tyson, MD MPH, University of Texas
Principal Investigator: James A. Lemons, MD, Indiana University
Principal Investigator: Lu-Ann Papile, MD, University of New Mexico