Development of Standards for the New Ballard Maturation Score (Ballard)
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| ClinicalTrials.gov Identifier: NCT01203449 |
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Recruitment Status :
Completed
First Posted : September 16, 2010
Last Update Posted : June 8, 2015
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| Condition or disease |
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| Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature Pregnancy |
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 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 : | June 1994 |
| Actual Primary Completion Date : | March 1996 |
| Actual Study Completion Date : | March 1996 |
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| Ages Eligible for Study: | up to 48 Hours (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01203449
| United States, California | |
| Stanford University | |
| Palo Alto, California, United States, 94304 | |
| United States, Connecticut | |
| Yale University | |
| New Haven, Connecticut, United States, 06504 | |
| United States, District of Columbia | |
| George Washington University | |
| Washington, District of Columbia, United States, 20052 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30303 | |
| United States, Indiana | |
| Indiana University | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Michigan | |
| Wayne State University | |
| Detroit, Michigan, United States, 48201 | |
| United States, New Mexico | |
| University of New Mexico | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, Ohio | |
| Cincinnati Children's Medical Center | |
| Cincinnati, Ohio, United States, 45267 | |
| Case Western Reserve University, Rainbow Babies and Children's Hospital | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Tennessee | |
| University of Tennessee | |
| Memphis, Tennessee, United States, 38163 | |
| United States, Texas | |
| University of Texas Southwestern Medical Center at Dallas | |
| Dallas, Texas, United States, 75235 | |
| 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 |
Publications of Results:
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NICHD Neonatal Research Network Extremely Low Birth Weight (ELBW) Prematurity Gestational Age |
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Birth Weight Body Weight |