Infant, Newborn Clinical Trial
Official title:
BilirubinProduction in Healthy Term Infants as Measured by Carbon Monoxide in Breath
Verified date | March 2019 |
Source | NICHD Neonatal Research Network |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 535 |
Est. completion date | November 1992 |
Est. primary completion date | November 1992 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 8 Hours |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - Any illness that would require admission to the neonatal intensive-care unit (NICU) within 8 hours of birth |
Country | Name | City | State |
---|---|---|---|
United States | University of New Mexico | Albuquerque | New Mexico |
United States | Emory University | Atlanta | Georgia |
United States | Cincinnati Children's Medical Center | Cincinnati | Ohio |
United States | Case Western Reserve University, Rainbow Babies and Children's Hospital | Cleveland | Ohio |
United States | University of Texas Southwestern Medical Center at Dallas | Dallas | Texas |
United States | Wayne State University | Detroit | Michigan |
United States | Indiana University | Indianapolis | Indiana |
United States | University of Tennessee | Memphis | Tennessee |
United States | University of Miami | Miami | Florida |
United States | Yale University | New Haven | Connecticut |
United States | Stanford University | Palo Alto | California |
United States | Brown University, Women & Infants Hospital of Rhode Island | Providence | Rhode Island |
United States | George Washington University | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
NICHD Neonatal Research Network |
United States,
Hintz 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 Paediat — View Citation
Stevenson 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. — View Citation
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. — View Citation
Vreman 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): — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | End-tidal carbon End-tidal carbon monoxide levels corrected for ambient air (ETCOc) | An index of bilirubin production | 2-8 hours of age |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04994652 -
Video- Or Direct Laryngoscopy for Endotracheal Intubation in Newborns
|
N/A | |
Completed |
NCT02064712 -
Determining an Optimal Weaning Method of Nasal Continuous Positive Airway Pressure in Preterm Neonates
|
N/A | |
Withdrawn |
NCT01335919 -
Neonatal Non-Invasive Hemoglobin Determination
|
N/A | |
Terminated |
NCT01192776 -
Optimizing (Longer, Deeper) Cooling for Neonatal Hypoxic-Ischemic Encephalopathy(HIE)
|
N/A | |
Completed |
NCT00114543 -
Trial of Aggressive Versus Conservative Phototherapy in Infants <1,000 Grams Birth Weight
|
Phase 3 | |
Completed |
NCT00011362 -
Dexamethasone Therapy in VLBW Infants at Risk of CLD
|
Phase 3 | |
Recruiting |
NCT05001334 -
Effect of Kangaroo Care on Phyiological Weight Loss in Term Newborns
|
N/A | |
Completed |
NCT01193270 -
Vitamin E for Extremely Preterm Infants
|
Phase 1 | |
Completed |
NCT00005772 -
Whole-Body Cooling for Birth Asphyxia in Term Infants
|
Phase 3 | |
Terminated |
NCT00005776 -
Inhaled Nitric Oxide Study for Respiratory Failure in Newborns
|
Phase 3 | |
Completed |
NCT01203423 -
Persistent Pulmonary Hypertension of the Newborn (PPHN) Observational Study
|
||
Completed |
NCT06120062 -
Effect of Swaddling and Inhaling Breast Milk Odour on the Pain and Comfort
|
||
Completed |
NCT00820677 -
Newborn Health Information Study
|
N/A | |
Active, not recruiting |
NCT00189384 -
Efficacy Study of Community-Based Treatment of Serious Bacterial Infections in Young Infants
|
Phase 3 | |
Recruiting |
NCT03745963 -
The Influence of Skin-to-skin Contact on Cortical Activity During Painful Procedures on Preterm Infants in the NICU
|
Phase 3 | |
Completed |
NCT04050384 -
Effect of a Vibratory Stimulus on Mitigating Nociception-specific Responses to Skin Puncture in Neonates
|
N/A | |
Completed |
NCT01793129 -
Preemie Hypothermia for Neonatal Encephalopathy
|
N/A | |
Withdrawn |
NCT00598429 -
Inhaled PGE1 in Neonatal Hypoxemic Respiratory Failure
|
Phase 2 | |
Completed |
NCT01223287 -
Physiologic Definition of Bronchopulmonary Dysplasia
|
N/A | |
Terminated |
NCT00005774 -
Early Surfactant to Reduce Use of Mechanical Breathing in Low Birth Weight Infants
|
Phase 3 |