Trial record 17 of 28 for:
necrotizing enterocolitis | NIH
Trial of Aggressive Versus Conservative Phototherapy in Infants <1,000 Grams Birth Weight
This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00114543
First received: June 15, 2005
Last updated: January 9, 2011
Last verified: September 2010
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Purpose
This multi-center, randomized clinical trial compared different bilirubin levels as thresholds for timing of phototherapy in extremely low birth weight infants. The primary hypothesis was that there would be no difference in death or neurodevelopmental impairment at 18-22 months corrected age in infants treated by either aggressive or conservative threshold limits. 1,978 infants were enrolled.
| Condition | Intervention | Phase |
|---|---|---|
|
Hyperbilirubinemia, Neonatal Jaundice, Neonatal Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature |
Procedure: Aggressive Phototherapy 501-750g Procedure: Aggressive Phototherapy 751-1000g Procedure: Conservative Phototherapy 501-750g Procedure: Conservative Phototherapy 751-1000g |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized Trial of Aggressive or Conservative Phototherapy for Extremely Low Birth Weight Infants |
Resource links provided by NLM:
Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Primary Outcome Measures:
- Death or neurodevelopmental impairment (MDI <70; PDI <70; cerebral palsy; blindness; or severe hearing loss) [ Time Frame: 0-22 months corrected age ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Patent ductus arteriosus requiring drug or surgical treatment [ Time Frame: 36 weeks post conceptual age ] [ Designated as safety issue: Yes ]
- Retinopathy of prematurity [ Time Frame: 36 weeks post conceptual age ] [ Designated as safety issue: Yes ]
- Bronchopulmonary dysplasia (BPD) [ Time Frame: 36 weeks post conceptual age ] [ Designated as safety issue: Yes ]
- Ventilator settings and FiO2 at 36 weeks [ Time Frame: 36 weeks post conceptual age ] [ Designated as safety issue: Yes ]
- Necrotizing enterocolitis (NEC) [ Time Frame: 120 days old or at discharge ] [ Designated as safety issue: Yes ]
- Intraventricular hemorrhage (IVH) by grade [ Time Frame: 120 days old or at discharge ] [ Designated as safety issue: Yes ]
- Periventricular leukomalacia [ Time Frame: 120 days old or at discharge ] [ Designated as safety issue: Yes ]
- Sepsis [ Time Frame: 120 days old or at discharge ] [ Designated as safety issue: Yes ]
- Hearing assessments [ Time Frame: 120 days old or at discharge ] [ Designated as safety issue: Yes ]
| Enrollment: | 1974 |
| Study Start Date: | September 2002 |
| Study Completion Date: | November 2007 |
| Primary Completion Date: | April 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Aggressive ELBW
In Aggressive group 1, infants with birth weights 501-750g.
|
Procedure: Aggressive Phototherapy 501-750g
Phototherapy started, stopped, and/or restarted when total serum bilirubin levels reach 5 mg/dl during days of life 1-14.
|
|
Active Comparator: Aggressive VLBW
In the Aggressive group 2, infants with birth weights 751-1000g.
|
Procedure: Aggressive Phototherapy 751-1000g
Phototherapy started, stopped, and/or restarted when total serum bilirubin levels reach 5 mg/dl during days of life 1-7, and started, stopped, and/or restarted when levels reach 7 mg/dl during days of life 8-14.
|
|
Active Comparator: Conservative ELBW
In the Conservative group 1, infants with birth weights 501-750g.
|
Procedure: Conservative Phototherapy 501-750g
Phototherapy started, stopped, and/or restarted when total serum bilirubin levels reach ≥8.0 mg/dl during days of life 1-14.
|
|
Active Comparator: Conservative VLBW
In the Conservative group 2, infants with birth weights 751-1000g.
|
Procedure: Conservative Phototherapy 751-1000g
Phototherapy started, stopped, and/or restarted when total serum bilirubin levels reach ≥10.0 mg/dl during days of life 1-14.
|
Detailed Description:
In NICHD Neonatal Research Network (NRN) centers in 2002, phototherapy was administered to 94 percent of the extremely low birth weight (ELBW) infants who survive more than 12 hours. Yet, it is unclear what level of bilirubin in the blood is harmful for these very tiny infants -- no data existed from large or recent clinical trials to define the risks, benefits, and appropriate indications for phototherapy in these infants. The largest and most recent trial was the NICHD Collaborative Phototherapy Trial which involved infants treated in 1974-1976 and included only 77 ELBW infants. Data from this study and others suggested that phototherapy could have important hazards as well as benefits for ELBW infants.
This NRN study used two different bilirubin levels as thresholds for timing of phototherapy in 1,978 extremely low birth weight infants, examining the primary hypothesis that there would be no difference in death or neurodevelopmental impairment at 18-22 months corrected age between the aggressively and conservatively treated groups.
Enrolled infants were stratified by birth weight (501-750g and 751-1,000g) and randomized to receive phototherapy regimens based on either an aggressive threshold or a conservative threshold of total serum bilirubin.
In the Aggressive group:
- 501-750 grams birth weight infants, phototherapy was started, stopped, and restarted based on a total serum bilirubin threshold level of 5 mg/dl for day of life 1-14.
- 751-1,000 grams birth weight infants, phototherapy was started, stopped, and restarted based on a total serum bilirubin threshold level of 5 mg/dl for day of life 1-7 and 7 mg/dl for day of life 8-14.
In the Conservative group:
- 501-750 grams birth weight infants, phototherapy was started, stopped, and restarted based on a total serum bilirubin threshold level of 8 mg/dl for day of life 1-14.
- 751-1,000 grams birth weight infants, phototherapy was started, stopped, and restarted based on a total serum bilirubin threshold level of 10 mg/dl for day of life 1-14.
The phototherapy regimens are designed to fall within the range of clinical practice and to assure a sizable difference between groups in total serum bilirubin levels and duration of phototherapy.
The primary outcome was death or neurodevelopmental impairment at 18-22 months corrected age determined at an outpatient clinic visit. Secondary outcomes included death, abnormal neurodevelopmental outcome, severe hearing loss, cerebral palsy, blindness, and important medical outcomes.
Eligibility| Ages Eligible for Study: | up to 36 Hours |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- 501-1000 grams birth weight
- 12-36 hours postnatal age
Exclusion criteria:
- Terminal condition (pH <6.8 for >2 hours OR persistent bradycardia, heart rate <100 bpm, associated with hypoxia for >2 hours]
- Prior use of phototherapy
- Major congenital anomaly
- Hydrops fetalis or severe hemolytic disease diagnosed in-utero
- Overt congenital nonbacterial infection
- Parental refusal or inability to provide consent
- Attending physician refusal
- Parents who are considered unlikely to return for follow-up evaluation
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00114543
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35233 | |
| United States, California | |
| Stanford University | |
| Palo Alto, California, United States, 94304 | |
| University of California at San Diego | |
| San Diego, California, United States, 92103-8774 | |
| United States, Connecticut | |
| Yale University | |
| New Haven, Connecticut, United States, 06504 | |
| United States, Florida | |
| University of Miami | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30303 | |
| United States, Indiana | |
| Indiana University | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Michigan | |
| Wayne State University | |
| Detroit, Michigan, United States, 48201 | |
| United States, New York | |
| University of Rochester | |
| Rochester, New York, United States, 14642 | |
| United States, North Carolina | |
| Wake Forest University | |
| Charlotte, North Carolina, United States, 27157 | |
| Duke University | |
| Durham, North Carolina, United States, 27710 | |
| RTI International | |
| Durham, North Carolina, United States, 27705 | |
| United States, Ohio | |
| Cincinnati Children's Medical Center | |
| Cincinnati, Ohio, United States, 45267 | |
| Case Western Reserve University, Rainbow Babies and Children's Hospital | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Rhode Island | |
| Brown University, Women & Infants Hospital of Rhode Island | |
| Providence, Rhode Island, United States, 02905 | |
| United States, Texas | |
| University of Texas Southwestern Medical Center at Dallas | |
| Dallas, Texas, United States, 75235 | |
| University of Texas Health Science Center at Houston | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Abbot R. Laptook, MD | Brown University, Women & Infants Hospital of Rhode Island |
| Principal Investigator: | Michele C. Walsh, MD MS | Case Western Reserve University, Rainbow Babies and Children's Hospital |
| Principal Investigator: | Ronald N. Goldberg, MD | Duke University |
| Principal Investigator: | Brenda B. Poindexter, MD MS | Indiana University |
| Principal Investigator: | Abhik Das, PhD | RTI International |
| Principal Investigator: | Ronnie Guillet, MD PhD | University of Rochester |
| Principal Investigator: | Pablo J. Sanchez, MD | University of Texas Southwestern Medical Center at Dallas |
| Principal Investigator: | Barbara J. Stoll, MD | Emory University |
| Principal Investigator: | Krisa P. Van Meurs, MD | Stanford University |
| Principal Investigator: | Neil N. Finer, MD | University of California, San Diego |
| Principal Investigator: | Kurt Schibler, MD | Cincinnati Children's Medical Center |
| Principal Investigator: | Waldemar A. Carlo, MD | University of Alabama at Birmingham |
| Principal Investigator: | Brenda H. Morris, MD | The University of Texas Health Science Center, Houston |
| Principal Investigator: | Seetha Shankaran, MD | Wayne State University |
| Principal Investigator: | Richard A. Ehrenkranz, MD | Yale University |
| Principal Investigator: | Shahnaz Duara, MD | University of Miami |
| Principal Investigator: | T. Michael O`Shea, MD MPH | Wake Forest University |
More Information
Additional Information:
Publications:
| Responsible Party: | Brenda H. Morris, Lead Principal Investigator, University of Texas Health Science Center at Houston |
| ClinicalTrials.gov Identifier: | NCT00114543 History of Changes |
| Other Study ID Numbers: | NICHD-NRN-0029, M01RR016587, M01RR000030, M01RR000032, M01RR000039, M01RR000044, M01RR006022, M01RR000633, M01RR000070, M01RR007122, M01RR000750, M01RR000080, M01RR008084, U01HD036790, U10HD021364, U10HD021373, U10HD021385, U10HD021397, U10HD027851, U10HD027853, U10HD027856, U10HD027871, U10HD027880, U10HD027904, U10HD034216, U10HD040461, U10HD040492, U10HD040498, U10HD040521, U10HD040689 |
| Study First Received: | June 15, 2005 |
| Last Updated: | January 9, 2011 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
NICHD Neonatal Research Network Bilirubin Phototherapy Very Low Birth Weight (VLBW) |
Extremely Low Birth Weight (ELBW) Prematurity Neurodevelopmental outcome |
Additional relevant MeSH terms:
|
Birth Weight Hyperbilirubinemia Jaundice Jaundice, Neonatal Hyperbilirubinemia, Neonatal |
Body Weight Signs and Symptoms Pathologic Processes Skin Manifestations Infant, Newborn, Diseases |
ClinicalTrials.gov processed this record on June 17, 2013