Infant, NewbornNCT01203410
Prediction of Jaundice in Term Infants
An observational study of Infant, Newborn and Jaundice, run by NICHD Neonatal Research Network at 13 sites in United States.
Trial summary
The objective of this study was to describe total bilirubin production in healthy term infants as a means of understanding the differences in jaundice pigment production associated with various common clinical circumstances. Read more about this study
- Who is it for?
- Ages Up to 8 hoursHealthy volunteers can take part
- Conditions the study is for
- Infant, Newborn, Jaundice
- How many people
- 535 participants
- Where
- 13 sitesUnited States
- Study dates
- Nov 1991to Nov 1992
- 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 8 hours
- All sexes
- Healthy volunteers accepted
- Child
Study population: Term infants.
Who may be able to join
- Infants born via cesarean delivery (to ensure subjects would still be hospitalized and available for ETCOc measurement and blood sampling on day 3 postpartum)
- Delivery within each center's scheduled recruitment period (to maximize nursing availability and minimize cost)
- Birth weight >2500 g
- Gestational age >37 weeks
Who cannot join
- Any illness that would require admission to the neonatal intensive-care unit (NICU) within 8 hours of birth
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 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
University of Miami
Miami, Florida, 33136
Yale University
New Haven, Connecticut, 06504
Stanford University
Palo Alto, California, 94304
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
George Washington University
Washington D.C., District of Columbia, 20052
About this study
Official title: BilirubinProduction in Healthy Term Infants as Measured by Carbon Monoxide in Breath
The objective of this study was to describe total bilirubin production in healthy term infants as a means of understanding the differences in jaundice pigment production associated with various common clinical circumstances.
Read the detailed description
Jaundice occurs in most human neonates during the several days after birth. The objective of this study was to describe total bilirubin production in healthy term infants as a means of understanding the differences in jaundice pigment production associated with various common clinical circumstances.
- Conditions
- Infant, Newborn, Jaundice
- Keywords
- NICHD Neonatal Research Network, Term infant, Hyperbilirubinemia
- Medical subject headings
- Jaundice, Hyperbilirubinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Term infants >2500g birthweight. |
What is being measured
The primary outcome is the main question the study is designed to answer.
End-tidal carbon End-tidal carbon monoxide levels corrected for ambient air (ETCOc)
An index of bilirubin production
Measured: 2-8 hours of age
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 startNov 1991
- Primary completionNov 1992
- Study completionNov 1992
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- 535 participants (actual)
Sponsor and investigators
- Lead sponsor
- NICHD Neonatal Research Network
- Sponsor type
- Research network
- Investigators
- David K. Stevenson, MD, Study director, Stanford UniversityWilliam Oh, MD, Principal investigator, Brown University, Women & Infants Hospital of Rhode IslandAvroy A. Fanaroff, MD, Principal investigator, Case Western Reserve UniversityJames A. Lemons, MD, Principal investigator, Indiana UniversityRaymond Bain, PhD, Principal investigator, George Washington UniversitySeetha Shankaran, MD, Principal investigator, Wayne State UniversityJon E. Tyson, MD, Principal investigator, University of TexasSheldon B. Korones, MD, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01203410
- Sponsor's protocol ID
- NICHD-NRN-0004
- Other IDs
- U10HD021364, U10HD027853, U10HD027851, U01HD019897, U10HD027856, U10HD027881, U10HD027880, U10HD021415
- Status last verified
- Mar 2019
- First submitted
- 15 Sep 2010
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Vreman HJ, Stevenson DK, Oh W, Fanaroff AA, Wright LL, Lemons JA, Wright E, Shankaran S, Tyson JE, Korones SB, et al. Semiportable electrochemical instrument for determining carbon monoxide in breath. Clin Chem. 1994 Oct;40(10):1927-33.
PubMed 7923774Stevenson DK, Vreman HJ, Oh W, Fanaroff AA, Wright LL, Lemons JA, Verter J, Shankaran S, Tyson JE, Korones SB, et al. Bilirubin production in healthy term infants as measured by carbon monoxide in breath. Clin Chem. 1994 Oct;40(10):1934-9.
PubMed 7923775Vreman HJ, Verter J, Oh W, Fanaroff AA, Wright LL, Lemons JA, Shankaran S, Tyson JE, Korones SB, Bauer CR, Stoll BJ, Papile LA, Donovan EF, Ehrenkranz RA, Stevenson DK. Interlaboratory variability of bilirubin measurements. Clin Chem. 1996 Jun;42(6 Pt 1):869-73.
PubMed 8665677Hintz SR, Gaylord TD, Oh W, Fanaroff AA, Mele L, Stevenson DK, Nichd FT; NICHD, Neonatal Research Network. Serum bilirubin levels at 72 hours by selected characteristics in breastfed and formula-fed term infants delivered by cesarean section. Acta Paediatr. 2001 Jul;90(7):776-81.
PubMed 11519981
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BilirubinProduction in Healthy Term Infants as Measured by Carbon Monoxide in Breath
- ClinicalTrials.gov ID
- NCT01203410
- Acronym / sponsor ID
- NICHD-NRN-0004
- Conditions
- Infant, Newborn, Jaundice
- Keywords
- NICHD Neonatal Research Network, Term infant, Hyperbilirubinemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 535 participants (actual)
- Lead sponsor
- NICHD Neonatal Research NetworkResearch network
- Study start
- Nov 1991
- Primary completion
- Nov 1992 (actual)
- Study completion
- Nov 1992 (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 objective of this study was to describe total bilirubin production in healthy term infants as a means of understanding the differences in jaundice pigment production associated with various common clinical circumstances.
Detailed description
Jaundice occurs in most human neonates during the several days after birth. The objective of this study was to describe total bilirubin production in healthy term infants as a means of understanding the differences in jaundice pigment production associated with various common clinical circumstances.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Term infants >2500g birthweight. |
Who may qualify
- Ages
- Up to 8 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Term infants.
Key inclusion criteria (4 listed)
- Infants born via cesarean delivery (to ensure subjects would still be hospitalized and available for ETCOc measurement and blood sampling on day 3 postpartum)
- Delivery within each center's scheduled recruitment period (to maximize nursing availability and minimize cost)
- Birth weight >2500 g
- Gestational age >37 weeks
Key exclusion criteria (1 listed)
- Any illness that would require admission to the neonatal intensive-care unit (NICU) within 8 hours of birth
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
End-tidal carbon End-tidal carbon monoxide levels corrected for ambient air (ETCOc)
Time frame: 2-8 hours of age
An index of bilirubin production
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 22 Mar 2019.
- Results publication: PubMed 7923774Vreman HJ, Stevenson DK, Oh W, Fanaroff AA, Wright LL, Lemons JA, Wright E, Shankaran S, Tyson JE, Korones SB, et al. Semiportable electrochemical instrument for determining carbon monoxide in breath. Clin Chem. 1994 Oct;40(10):1927-33.
- Results publication: PubMed 7923775Stevenson DK, Vreman HJ, Oh W, Fanaroff AA, Wright LL, Lemons JA, Verter J, Shankaran S, Tyson JE, Korones SB, et al. Bilirubin production in healthy term infants as measured by carbon monoxide in breath. Clin Chem. 1994 Oct;40(10):1934-9.
- Results publication: PubMed 8665677Vreman HJ, Verter J, Oh W, Fanaroff AA, Wright LL, Lemons JA, Shankaran S, Tyson JE, Korones SB, Bauer CR, Stoll BJ, Papile LA, Donovan EF, Ehrenkranz RA, Stevenson DK. Interlaboratory variability of bilirubin measurements. Clin Chem. 1996 Jun;42(6 Pt 1):869-73.
- Results publication: PubMed 11519981Hintz SR, Gaylord TD, Oh W, Fanaroff AA, Mele L, Stevenson DK, Nichd FT; NICHD, Neonatal Research Network. Serum bilirubin levels at 72 hours by selected characteristics in breastfed and formula-fed term infants delivered by cesarean section. Acta Paediatr. 2001 Jul;90(7):776-81.
- NICHD Neonatal Research NetworkLink provided by the sponsor.
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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.
David K. Stevenson, MD study director
Stanford University
William Oh, MD principal investigator
Brown University, Women & Infants Hospital of Rhode Island
Avroy A. Fanaroff, MD principal investigator
Case Western Reserve University
13 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 Jaundice, run by NICHD Neonatal Research Network at 13 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 4 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 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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.
What does the primary outcome measure?
End-tidal carbon End-tidal carbon monoxide levels corrected for ambient air (ETCOc) (time frame: 2-8 hours of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01203410, which also lists 4 linked publications.
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 22 Mar 2019.