Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114543
Status:
COMPLETED
Last Update Posted:
2019-03-22
First Post:
2005-06-15
Brief Title:
Trial of Aggressive Versus Conservative Phototherapy in Infants 1000 Grams Birth Weight
Sponsor:
NICHD Neonatal Research Network
Organization:
NICHD Neonatal Research Network
Study Overview
Official Title:
A Randomized Trial of Aggressive or Conservative Phototherapy for Extremely Low Birth Weight Infants
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Phototherapy
Brief 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 either aggressive or conservative threshold limits 1978 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 1978 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 751-1000g 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 mgdl for day of life 1-14
751-1000 grams birth weight infants phototherapy was started stopped and restarted based on a total serum bilirubin threshold level of 5 mgdl for day of life 1-7 and 7 mgdl 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 mgdl for day of life 1-14
751-1000 grams birth weight infants phototherapy was started stopped and restarted based on a total serum bilirubin threshold level of 10 mgdl 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
This NRN study used two different bilirubin levels as thresholds for timing of phototherapy in 1978 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 751-1000g 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 mgdl for day of life 1-14
751-1000 grams birth weight infants phototherapy was started stopped and restarted based on a total serum bilirubin threshold level of 5 mgdl for day of life 1-7 and 7 mgdl 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 mgdl for day of life 1-14
751-1000 grams birth weight infants phototherapy was started stopped and restarted based on a total serum bilirubin threshold level of 10 mgdl 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10HD040689 | NIH | None | httpsreporternihgovquickSearchU10HD040689 |
| M01RR016587 | NIH | None | None |
| M01RR000030 | NIH | None | None |
| M01RR000032 | NIH | None | None |
| M01RR000039 | NIH | None | None |
| M01RR000044 | NIH | None | None |
| M01RR006022 | NIH | None | None |
| M01RR000633 | NIH | None | None |
| M01RR000070 | NIH | None | None |
| M01RR007122 | NIH | None | None |
| M01RR000750 | NIH | None | None |
| M01RR000080 | NIH | None | None |
| M01RR008084 | NIH | None | None |
| U01HD036790 | NIH | None | None |
| U10HD021364 | NIH | None | None |
| U10HD021373 | NIH | None | None |
| U10HD021385 | NIH | None | None |
| U10HD021397 | NIH | None | None |
| U10HD027851 | NIH | None | None |
| U10HD027853 | NIH | None | None |
| U10HD027856 | NIH | None | None |
| U10HD027871 | NIH | None | None |
| U10HD027880 | NIH | None | None |
| U10HD027904 | NIH | None | None |
| U10HD034216 | NIH | None | None |
| U10HD040461 | NIH | None | None |
| U10HD040492 | NIH | None | None |
| U10HD040498 | NIH | None | None |
| U10HD040521 | NIH | None | None |