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Development of Standards for the New Ballard Maturation Score
NCT01203449 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Study Locations (11)
Ohio
- Cincinnati Children's Medical Center — Cincinnati
- Case Western Reserve University, Rainbow Babies and Children's Hospital — Cleveland
California
- Stanford University — Palo Alto
Connecticut
- Yale University — New Haven
District of Columbia
- George Washington University — Washington D.C.
Georgia
- Emory University — Atlanta
Indiana
- Indiana University — Indianapolis
Michigan
- Wayne State University — Detroit
New Mexico
- University of New Mexico — Albuquerque
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,090 participants |
| Start Date | 1994-06 |
| Est. Completion | 1996-03 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01203449
The ClinicalTrials.gov registry entry for NCT01203449 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,090 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NICHD Neonatal Research Network, which has 44 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Pregnancy appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01203449 reports 11 study locations spanning 10 distinct geographic areas — top geographies include Ohio, California, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01203449 about?
NCT01203449 is a clinical study titled "Development of Standards for the New Ballard Maturation Score". 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 ...
What is the current status of trial NCT01203449?
This trial is currently completed. The enrollment target is 1,090 participants. The study started on 1994-06. Estimated completion is 1996-03.
What conditions does trial NCT01203449 study?
This clinical trial studies the following conditions: Pregnancy, Infant, Newborn, Infant, Premature, Infant, Small for Gestational Age, Infant, Low Birth Weight. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT01203449?
This trial is sponsored by NICHD Neonatal Research Network, which has 44 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01203449 being conducted?
This trial has 11 study locations across California, Connecticut, District of Columbia, Georgia, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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