Hyperbilirubinemia, NeonatalPhase 3PhototherapyNCT00114543
Trial of Aggressive Versus Conservative Phototherapy in Infants <1,000 Grams Birth Weight
A Phase 3 study testing Aggressive Phototherapy 501-750g, Aggressive Phototherapy 751-1000g and Conservative Phototherapy 501-750g in people with Hyperbilirubinemia, Neonatal and Jaundice, Neonatal, run by NICHD Neonatal Research Network at 17 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 to 36 hours
- Conditions the study is for
- Hyperbilirubinemia, Neonatal, Jaundice, Neonatal, Infant, Newborn
- What is being tested?
- Aggressive Phototherapy 501-750g, Aggressive Phototherapy 751-1000g and Conservative Phototherapy 501-750g
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,974 participants
- Where
- 17 sitesUnited States
- Study dates
- Sep 2002to Nov 2007
- Phase
- Phase 3
- 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 12 to 36 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 501-1000 grams birth weight
- 12-36 hours postnatal age
Who cannot join
- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Emory University
Atlanta, Georgia, 30303
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Wake Forest University
Charlotte, North Carolina, 27157
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
RTI International
Durham, North Carolina, 27705
Duke University
Durham, North Carolina, 27710
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
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
University of Rochester
Rochester, New York, 14642
University of California at San Diego
San Diego, California, 92103-8774
About this study
Official title: A Randomized Trial of Aggressive or Conservative Phototherapy for Extremely Low Birth Weight Infants
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.
Read the 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.
- Conditions
- Hyperbilirubinemia, Neonatal, Jaundice, Neonatal, Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Being tested
- Aggressive Phototherapy 501-750g, Aggressive Phototherapy 751-1000g, Conservative Phototherapy 501-750g, Conservative Phototherapy 751-1000g
- Keywords
- NICHD Neonatal Research Network, Bilirubin, Phototherapy, Very Low Birth Weight (VLBW), Extremely Low Birth Weight (ELBW), Prematurity, Neurodevelopmental outcome
- Medical subject headings
- Hyperbilirubinemia, Neonatal, Jaundice, Neonatal, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aggressive Phototherapy 501-750gProcedure or surgery
Phototherapy started, stopped, and/or restarted when total serum bilirubin levels reach 5 mg/dl during days of life 1-14.
Aggressive Phototherapy 751-1000gProcedure or surgery
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.
Conservative Phototherapy 501-750gProcedure or surgery
Phototherapy started, stopped, and/or restarted when total serum bilirubin levels reach ≥8.0 mg/dl during days of life 1-14.
Conservative Phototherapy 751-1000gProcedure or surgery
Phototherapy started, stopped, and/or restarted when total serum bilirubin levels reach ≥10.0 mg/dl during days of life 1-14.
| Study group | Role | What they receive |
|---|---|---|
| Aggressive ELBW | Active comparator | In Aggressive group 1, infants with birth weights 501-750g. Receives: Procedure: Aggressive Phototherapy 501-750g |
| Aggressive VLBW | Active comparator | In the Aggressive group 2, infants with birth weights 751-1000g. Receives: Procedure: Aggressive Phototherapy 751-1000g |
| Conservative ELBW | Active comparator | In the Conservative group 1, infants with birth weights 501-750g. Receives: Procedure: Conservative Phototherapy 501-750g |
| Conservative VLBW | Active comparator | In the Conservative group 2, infants with birth weights 751-1000g. Receives: Procedure: Conservative Phototherapy 751-1000g |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death or neurodevelopmental impairment (MDI <70; PDI <70; cerebral palsy; blindness; or severe hearing loss)
Measured: 0-22 months corrected age
Secondary outcomes (9)
Patent ductus arteriosus requiring drug or surgical treatment
Measured: 36 weeks post conceptual age
Retinopathy of prematurity
Measured: 36 weeks post conceptual age
Bronchopulmonary dysplasia (BPD)
Measured: 36 weeks post conceptual age
Ventilator settings and FiO2 at 36 weeks
Measured: 36 weeks post conceptual age
Necrotizing enterocolitis (NEC)
Measured: 120 days old or at discharge
Intraventricular hemorrhage (IVH) by grade
Measured: 120 days old or at discharge
Periventricular leukomalacia
Measured: 120 days old or at discharge
Sepsis
Measured: 120 days old or at discharge
Hearing assessments
Measured: 120 days old or at discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2005 (estimated)
- Study startSep 2002
- Primary completionApr 2005
- Study completionNov 2007
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 Hyperbilirubinemia, NeonatalStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,974 participants (actual)
Sponsor and investigators
- Lead sponsor
- NICHD Neonatal Research Network
- Sponsor type
- Research network
- Collaborators
- National Center for Research Resources (NCRR)
- Investigators
- Abbot R. Laptook, MD, Principal investigator, Brown University, Women & Infants Hospital of Rhode IslandMichele C. Walsh, MD MS, Principal investigator, Case Western Reserve University, Rainbow Babies and Children's HospitalRonald N. Goldberg, MD, Principal investigator, Duke UniversityBrenda B. Poindexter, MD MS, Principal investigator, Indiana UniversityAbhik Das, PhD, Principal investigator, RTI InternationalRonnie Guillet, MD PhD, Principal investigator, University of RochesterPablo J. Sanchez, MD, Principal investigator, University of Texas, Southwestern Medical Center at DallasBarbara J. Stoll, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00114543
- Sponsor's protocol ID
- NICHD-NRN-0029
- Other IDs
- M01RR016587, M01RR000030, M01RR000032, M01RR000039, M01RR000044, M01RR006022, M01RR000633, M01RR000070
- Acronym
- Phototherapy
- Status last verified
- Sep 2017
- First submitted
- 15 Jun 2005
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Morris BH, Oh W, Tyson JE, Stevenson DK, Phelps DL, O'Shea TM, McDavid GE, Perritt RL, Van Meurs KP, Vohr BR, Grisby C, Yao Q, Pedroza C, Das A, Poole WK, Carlo WA, Duara S, Laptook AR, Salhab WA, Shankaran S, Poindexter BB, Fanaroff AA, Walsh MC, Rasmussen MR, Stoll BJ, Cotten CM, Donovan EF, Ehrenkranz RA, Guillet R, Higgins RD; NICHD Neonatal Research Network. Aggressive vs. conservative phototherapy for infants with extremely low birth weight. N Engl J Med. 2008 Oct 30;359(18):1885-96. doi: 10.1056/NEJMoa0803024.
PubMed 18971491Ahlfors CE, Vreman HJ, Wong RJ, Bender GJ, Oh W, Morris BH, Stevenson DK; Phototherapy Subcommittee; National Institute of Child Health and Development (NICHD) Neonatal Research Network. Effects of sample dilution, peroxidase concentration, and chloride ion on the measurement of unbound bilirubin in premature newborns. Clin Biochem. 2007 Feb;40(3-4):261-7. doi: 10.1016/j.clinbiochem.2006.09.006. Epub 2006 Sep 29.
PubMed 17069786Bender GJ, Cashore WJ, Oh W. Ontogeny of bilirubin-binding capacity and the effect of clinical status in premature infants born at less than 1300 grams. Pediatrics. 2007 Nov;120(5):1067-73. doi: 10.1542/peds.2006-3024.
PubMed 17974745Oh W, Stevenson DK, Tyson JE, Morris BH, Ahlfors CE, Bender GJ, Wong RJ, Perritt R, Vohr BR, Van Meurs KP, Vreman HJ, Das A, Phelps DL, O'Shea TM, Higgins RD; NICHD Neonatal Research Network Bethesda MD. Influence of clinical status on the association between plasma total and unbound bilirubin and death or adverse neurodevelopmental outcomes in extremely low birth weight infants. Acta Paediatr. 2010 May;99(5):673-678. doi: 10.1111/j.1651-2227.2010.01688.x. Epub 2010 Jan 25.
PubMed 20105142
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
- A Randomized Trial of Aggressive or Conservative Phototherapy for Extremely Low Birth Weight Infants
- ClinicalTrials.gov ID
- NCT00114543
- Acronym / sponsor ID
- Phototherapy / NICHD-NRN-0029
- Conditions
- Hyperbilirubinemia, Neonatal, Jaundice, Neonatal, Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Keywords
- NICHD Neonatal Research Network, Bilirubin, Phototherapy, Very Low Birth Weight (VLBW), Extremely Low Birth Weight (ELBW), Prematurity, Neurodevelopmental outcome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,974 participants (actual)
- Lead sponsor
- NICHD Neonatal Research NetworkResearch network
- Collaborators
- National Center for Research Resources (NCRR)
- Study start
- Sep 2002
- Primary completion
- Apr 2005 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 16 Jun 2005 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Aggressive ELBW | Active comparator | Procedure: Aggressive Phototherapy 501-750gIn Aggressive group 1, infants with birth weights 501-750g. |
| Aggressive VLBW | Active comparator | Procedure: Aggressive Phototherapy 751-1000gIn the Aggressive group 2, infants with birth weights 751-1000g. |
| Conservative ELBW | Active comparator | Procedure: Conservative Phototherapy 501-750gIn the Conservative group 1, infants with birth weights 501-750g. |
| Conservative VLBW | Active comparator | Procedure: Conservative Phototherapy 751-1000gIn the Conservative group 2, infants with birth weights 751-1000g. |
Who may qualify
- Ages
- 12 to 36 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 501-1000 grams birth weight
- 12-36 hours postnatal age
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aggressive Phototherapy 501-750gPhototherapy started, stopped, and/or restarted when total serum bilirubin levels reach 5 mg/dl during days of life 1-14. | Procedure or surgery | Aggressive ELBW |
| Aggressive Phototherapy 751-1000gPhototherapy 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. | Procedure or surgery | Aggressive VLBW |
| Conservative Phototherapy 501-750gPhototherapy started, stopped, and/or restarted when total serum bilirubin levels reach ≥8.0 mg/dl during days of life 1-14. | Procedure or surgery | Conservative ELBW |
| Conservative Phototherapy 751-1000gPhototherapy started, stopped, and/or restarted when total serum bilirubin levels reach ≥10.0 mg/dl during days of life 1-14. | Procedure or surgery | Conservative VLBW |
Primary outcome
Death or neurodevelopmental impairment (MDI <70; PDI <70; cerebral palsy; blindness; or severe hearing loss)
Time frame: 0-22 months corrected age
9 secondary outcomes
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
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 18971491Morris BH, Oh W, Tyson JE, Stevenson DK, Phelps DL, O'Shea TM, McDavid GE, Perritt RL, Van Meurs KP, Vohr BR, Grisby C, Yao Q, Pedroza C, Das A, Poole WK, Carlo WA, Duara S, Laptook AR, Salhab WA, Shankaran S, Poindexter BB, Fanaroff AA, Walsh MC, Rasmussen MR, Stoll BJ, Cotten CM, Donovan EF, Ehrenkranz RA, Guillet R, Higgins RD; NICHD Neonatal Research Network. Aggressive vs. conservative phototherapy for infants with extremely low birth weight. N Engl J Med. 2008 Oct 30;359(18):1885-96. doi: 10.1056/NEJMoa0803024.
- Results publication: PubMed 17069786Ahlfors CE, Vreman HJ, Wong RJ, Bender GJ, Oh W, Morris BH, Stevenson DK; Phototherapy Subcommittee; National Institute of Child Health and Development (NICHD) Neonatal Research Network. Effects of sample dilution, peroxidase concentration, and chloride ion on the measurement of unbound bilirubin in premature newborns. Clin Biochem. 2007 Feb;40(3-4):261-7. doi: 10.1016/j.clinbiochem.2006.09.006. Epub 2006 Sep 29.
- Results publication: PubMed 17974745Bender GJ, Cashore WJ, Oh W. Ontogeny of bilirubin-binding capacity and the effect of clinical status in premature infants born at less than 1300 grams. Pediatrics. 2007 Nov;120(5):1067-73. doi: 10.1542/peds.2006-3024.
- Results publication: PubMed 20105142Oh W, Stevenson DK, Tyson JE, Morris BH, Ahlfors CE, Bender GJ, Wong RJ, Perritt R, Vohr BR, Van Meurs KP, Vreman HJ, Das A, Phelps DL, O'Shea TM, Higgins RD; NICHD Neonatal Research Network Bethesda MD. Influence of clinical status on the association between plasma total and unbound bilirubin and death or adverse neurodevelopmental outcomes in extremely low birth weight infants. Acta Paediatr. 2010 May;99(5):673-678. doi: 10.1111/j.1651-2227.2010.01688.x. Epub 2010 Jan 25.
- 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.
Abbot R. Laptook, MD principal investigator
Brown University, Women & Infants Hospital of Rhode Island
Michele C. Walsh, MD MS principal investigator
Case Western Reserve University, Rainbow Babies and Children's Hospital
Ronald N. Goldberg, MD principal investigator
Duke University
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aggressive Phototherapy 501-750g, Aggressive Phototherapy 751-1000g and Conservative Phototherapy 501-750g in people with Hyperbilirubinemia, Neonatal and Jaundice, Neonatal, run by NICHD Neonatal Research Network at 17 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 2 inclusion and 8 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 17 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Death or neurodevelopmental impairment (MDI <70; PDI <70; cerebral palsy; blindness; or severe hearing loss) (time frame: 0-22 months corrected 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 NCT00114543, 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.