Development of Standards for the New Ballard Maturation Score

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01203449
First received: September 15, 2010
Last updated: January 9, 2011
Last verified: September 2010

September 15, 2010
January 9, 2011
June 1994
March 1996   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01203449 on ClinicalTrials.gov Archive Site
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Development of Standards for the New Ballard Maturation Score
Development of Standards for the New Ballard Maturation Score

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Infants born in the NICHD Neonatal Research Network during the study period.

  • Infant, Newborn
  • Infant, Low Birth Weight
  • Infant, Small for Gestational Age
  • Infant, Premature
  • Pregnancy
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Donovan EF, Tyson JE, Ehrenkranz RA, Verter J, Wright LL, Korones SB, Bauer CR, Shankaran S, Stoll BJ, Fanaroff AA, Oh W, Lemons JA, Stevenson DK, Papile LA. Inaccuracy of Ballard scores before 28 weeks' gestation. National Institute of Child Health and Human Development Neonatal Research Network. J Pediatr. 1999 Aug;135(2 Pt 1):147-52.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1090
March 1996
March 1996   (final data collection date for primary outcome measure)

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
Both
up to 48 Hours
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01203449
NICHD-NRN-0012, U10HD027853, U10HD027871, U10HD021385, U10HD027880, U01HD019897, U10HD021364, U10HD021415, U10HD027851, U10HD021373, U10HD027856, U10HD027881, M01RR008084, M01RR006022, M01RR000750, M01RR000070, M01RR000997, U10HD021397
No
Edward F. Donovan/ Lead Principal Investigator, Cincinnati Children's Medical Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Center for Research Resources (NCRR)
Study Director: Edward F. Donovan, MD Cincinnati Children's Medical Center
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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP