Infant, NewbornBallardNCT01203449
Development of Standards for the New Ballard Maturation Score
An observational study of Infant, Newborn and Infant, Low Birth Weight, run by NICHD Neonatal Research Network at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 48 hoursHealthy volunteers can take part
- Conditions the study is for
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age
- How many people
- 1,090 participants
- Where
- 11 sitesUnited States
- Study dates
- Jun 1994to Mar 1996
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 48 hours
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants born in the NICHD Neonatal Research Network during the study period.
Who may be able to join
- <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.
Who cannot join
- Inaccurate or unavailable menstrual histories
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of New Mexico
Albuquerque, New Mexico, 87131
Emory University
Atlanta, Georgia, 30303
Cincinnati Children's Medical Center
Cincinnati, Ohio, 45267
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235
Wayne State University
Detroit, Michigan, 48201
Indiana University
Indianapolis, Indiana, 46202
University of Tennessee
Memphis, Tennessee, 38163
Yale University
New Haven, Connecticut, 06504
Stanford University
Palo Alto, California, 94304
George Washington University
Washington D.C., District of Columbia, 20052
About this study
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.
Read the 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.
- 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
- Medical subject headings
- Premature Birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study startJun 1994
- Primary completionMar 1996
- Study completionMar 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant, NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,090 participants (actual)
Sponsor and investigators
- Lead sponsor
- NICHD Neonatal Research Network
- Sponsor type
- Research network
- Collaborators
- National Center for Research Resources (NCRR)
- Investigators
- Edward F. Donovan, MD, Study director, Children's Hospital Medical Center, CincinnatiRichard A. Ehrenkranz, MD, Principal investigator, Yale UniversitySeetha Shankaran, MD, Principal investigator, Wayne State UniversityDavid K. Stevenson, MD, Principal investigator, Stanford UniversityRaymond Bain, PhD, Principal investigator, George Washington UniversityAvroy A. Fanaroff, MD, Principal investigator, Case Western Reserve UniversitySheldon B. Korones, MD, Principal investigator, University of Tennessee at MemphisBarbara J. Stoll, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01203449
- Sponsor's protocol ID
- NICHD-NRN-0012
- Other IDs
- U10HD027853, U10HD027871, U10HD021385, U10HD027880, U01HD019897, U10HD021364, U10HD021415, U10HD027851
- Acronym
- Ballard
- Status last verified
- Jun 2015
- First submitted
- 15 Sep 2010
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 10431107
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Standards for the New Ballard Maturation Score
- ClinicalTrials.gov ID
- NCT01203449
- Acronym / sponsor ID
- Ballard / NICHD-NRN-0012
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,090 participants (actual)
- Lead sponsor
- NICHD Neonatal Research NetworkResearch network
- Collaborators
- National Center for Research Resources (NCRR)
- Study start
- Jun 1994
- Primary completion
- Mar 1996 (actual)
- Study completion
- Mar 1996 (actual)
- First posted
- 16 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 48 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants born in the NICHD Neonatal Research Network during the study period.
Key inclusion criteria (8 listed)
- <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
Key exclusion criteria (1 listed)
- Inaccurate or unavailable menstrual histories
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2015.
- Results publication: PubMed 10431107Donovan 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.
- NICHD Neonatal Research NetworkLink provided by the sponsor.
Related trials for Infant, Newborn
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Active, not recruitingPhase 1
A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725
Netherton Syndrome
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward F. Donovan, MD study director
Children's Hospital Medical Center, Cincinnati
Richard A. Ehrenkranz, MD principal investigator
Yale University
Seetha Shankaran, MD principal investigator
Wayne State University
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant, Newborn and Infant, Low Birth Weight, run by NICHD Neonatal Research Network at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01203449, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2015.