Trial of Aggressive Versus Conservative Phototherapy in Infants <1,000 Grams Birth Weight (Phototherapy)
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| ClinicalTrials.gov Identifier: NCT00114543 |
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Recruitment Status :
Completed
First Posted : June 16, 2005
Last Update Posted : March 22, 2019
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| Condition or disease | Intervention/treatment | 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 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1974 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized Trial of Aggressive or Conservative Phototherapy for Extremely Low Birth Weight Infants |
| Study Start Date : | September 2002 |
| Actual Primary Completion Date : | April 2005 |
| Actual Study Completion Date : | November 2007 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Aggressive ELBW
In Aggressive group 1, infants with birth weights 501-750g.
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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. |
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Active Comparator: Aggressive VLBW
In the Aggressive group 2, infants with birth weights 751-1000g.
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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. |
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Active Comparator: Conservative ELBW
In the Conservative group 1, infants with birth weights 501-750g.
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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. |
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Active Comparator: Conservative VLBW
In the Conservative group 2, infants with birth weights 751-1000g.
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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. |
- Death or neurodevelopmental impairment (MDI <70; PDI <70; cerebral palsy; blindness; or severe hearing loss) [ Time Frame: 0-22 months corrected age ]
- Patent ductus arteriosus requiring drug or surgical treatment [ Time Frame: 36 weeks post conceptual age ]
- Retinopathy of prematurity [ Time Frame: 36 weeks post conceptual age ]
- Bronchopulmonary dysplasia (BPD) [ Time Frame: 36 weeks post conceptual age ]
- Ventilator settings and FiO2 at 36 weeks [ Time Frame: 36 weeks post conceptual age ]
- Necrotizing enterocolitis (NEC) [ Time Frame: 120 days old or at discharge ]
- Intraventricular hemorrhage (IVH) by grade [ Time Frame: 120 days old or at discharge ]
- Periventricular leukomalacia [ Time Frame: 120 days old or at discharge ]
- Sepsis [ Time Frame: 120 days old or at discharge ]
- Hearing assessments [ Time Frame: 120 days old or at discharge ]
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| Ages Eligible for Study: | 12 Hours to 36 Hours (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00114543
Show 17 study locations
| 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 | Children's Hospital Medical Center, Cincinnati | |
| 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 |
Publications of Results:
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NICHD Neonatal Research Network Bilirubin Phototherapy Very Low Birth Weight (VLBW) |
Extremely Low Birth Weight (ELBW) Prematurity Neurodevelopmental outcome |
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Jaundice, Neonatal Hyperbilirubinemia, Neonatal Body Weight Birth Weight Jaundice |
Hyperbilirubinemia Pathologic Processes Skin Manifestations Infant, Newborn, Diseases |