Development of Standards for the New Ballard Maturation Score
Trial ID or NCT#
NCT01203449
Status
NOT RECRUITING
Purpose
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.
Official Title
Development of Standards for the New Ballard Maturation Score
Eligibility Criteria
Ages Eligible for Study: Younger than 48 Hours
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
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
Investigator(s)
David K. Stevenson, M.D.
View on ClinicalTrials.gov
