Development of Standards for the New Ballard Maturation Score

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1090 participants

Study Classification

OBSERVATIONAL

Study Start Date

1994-06-30

Study Completion Date

1996-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Growth Observational Study

NCT01203475

Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age +1 more

COMPLETED

Reproducibility of a New Practical Newborn Behavioral Observation Scale

NCT02844205

Premature Newborn

UNKNOWN

Linear Growth and Neurobehavioural Outcome in PT Neonates (<34 Wks) at 37 and 40 Wks of CGA

NCT02970994

PreTerm Birth

COMPLETED

Gestational Age Assessment Tool

NCT02534194

Immature Newborn Premature Birth

COMPLETED

Generic Database of Moderate Preterm Infants

NCT01793116

Infant, Newborn Infant, Moderate Preterm

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Maximum Eligible Age

48 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Cincinnati Children's Medical Center

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Edward F. Donovan, MD

Role: STUDY_DIRECTOR

Children's Hospital Medical Center, Cincinnati

Richard A. Ehrenkranz, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Seetha Shankaran, MD

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

David K. Stevenson, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Raymond Bain, PhD

Role: PRINCIPAL_INVESTIGATOR

George Washington University

Avroy A. Fanaroff, MD

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Sheldon B. Korones, MD

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee at Memphis

Barbara J. Stoll, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Jon E. Tyson, MD MPH

Role: PRINCIPAL_INVESTIGATOR

University of Texas

James A. Lemons, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Lu-Ann Papile, MD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Stanford University

Palo Alto, California, United States

Site Status

Yale University

New Haven, Connecticut, United States

Site Status

George Washington University

Washington D.C., District of Columbia, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Indiana University

Indianapolis, Indiana, United States

Site Status

Wayne State University

Detroit, Michigan, United States

Site Status

University of New Mexico

Albuquerque, New Mexico, United States

Site Status

Cincinnati Children's Medical Center

Cincinnati, Ohio, United States

Site Status

Case Western Reserve University, Rainbow Babies and Children's Hospital

Cleveland, Ohio, United States

Site Status

University of Tennessee

Memphis, Tennessee, United States

Site Status

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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. doi: 10.1016/s0022-3476(99)70015-6.

Reference Type RESULT

PMID: 10431107 (View on PubMed)