NCT01203449

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,090

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 1994

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1994

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 1996

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 1996

Completed
14.6 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2010

Completed
Last Updated

June 8, 2015

Status Verified

June 1, 2015

Enrollment Period

1.8 years

First QC Date

September 15, 2010

Last Update Submit

June 3, 2015

Conditions

Infant, NewbornInfant, Low Birth WeightInfant, Small for Gestational AgeInfant, PrematurePregnancy

Keywords

NICHD Neonatal Research NetworkExtremely Low Birth Weight (ELBW)PrematurityGestational Age

Eligibility Criteria

AgeUp to 48 Hours
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Stanford University

Palo Alto, California, 94304, United States

Location

Yale University

New Haven, Connecticut, 06504, United States

Location

George Washington University

Washington D.C., District of Columbia, 20052, United States

Location

Emory University

Atlanta, Georgia, 30303, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Cincinnati Children's Medical Center

Cincinnati, Ohio, 45267, United States

Location

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

Cleveland, Ohio, 44106, United States

Location

University of Tennessee

Memphis, Tennessee, 38163, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75235, United States

Location

Related Publications (1)

  • 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.

    PMID: 10431107RESULT

Related Links

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Edward F. Donovan, MD

    Children's Hospital Medical Center, Cincinnati

    STUDY DIRECTOR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK

Study Record Dates

First Submitted

September 15, 2010

First Posted

September 16, 2010

Study Start

June 1, 1994

Primary Completion

March 1, 1996

Study Completion

March 1, 1996

Last Updated

June 8, 2015

Record last verified: 2015-06

Locations

US(11)