Clinical trial NCT01203449: Development of Standards for the New Ballard Maturation Score
Official title: Development of Standards for the New Ballard Maturation Score
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant, Newborn
Infant, Low Birth Weight
Infant, Small for Gestational Age
Infant, Premature
Pregnancy
Keywords: NICHD Neonatal Research Network
Extremely Low Birth Weight (ELBW)
Prematurity
Gestational Age
Lead sponsor: NICHD Neonatal Research Network
Sponsor class: NETWORK
Collaborators: name: National Center for Research Resources (NCRR)
First posted: 2010-09-16
Enrollment: 1090
Sex: ALL
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infants born in the NICHD Neonatal Research Network during the study period.

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.

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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Cincinnati
country: United States
facility: Cincinnati Children's Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Case Western Reserve University, Rainbow Babies and Children's Hospital
state: Ohio
city: Memphis
country: United States
facility: University of Tennessee
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Edward F. Donovan, MD
role: STUDY_DIRECTOR
affiliation: Yale University
name: Richard A. Ehrenkranz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wayne State University
name: Seetha Shankaran, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: David K. Stevenson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: George Washington University
name: Raymond Bain, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Case Western Reserve University
name: Avroy A. Fanaroff, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Tennessee at Memphis
name: Sheldon B. Korones, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Barbara J. Stoll, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas
name: Jon E. Tyson, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University
name: James A. Lemons, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of New Mexico
name: Lu-Ann Papile, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.