Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00009646
Status:
COMPLETED
Last Update Posted:
2015-06-08
First Post:
2001-02-01
Brief Title:
Trial of Indomethacin Prophylaxis in Preterm Infants TIPP
Sponsor:
NICHD Neonatal Research Network
Organization:
NICHD Neonatal Research Network
Study Overview
Official Title:
Trial of Indomethacin Prophylaxis in Preterm Infants TIPP
Status:
COMPLETED
Status Verified Date:
2015-06
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:
TIPP
Brief Summary:
This trial was to determine whether giving low-dose indomethacin to infants weight 500 to 999 grams approximately 1 to 2 pounds at birth improves their survival without cerebral palsy or developmental problems at 18 to 22 months of age
Detailed Description:
Prophylactic indomethacin reduces patent ductus arteriosus PDA and intraventricular hemorrhage in very low birth weight infants However the effects of early indomethacin on long-term neurodevelopment remain uncertain There is also insufficient evidence to rule out serious adverse effects such as increases in the risk of necrotizing enterocolitis NEC and retinopathy of prematurity ROP The aim of this trial was to determine if prophylactic administration of indomethacin improves survival without neurosensory impairments in extremely-low-birth-weight infants Infants n1202 with birthweights 500 to 999 grams were randomized between 2 and 6 hours after birth to receive either intravenous indomethacin 01 mgkg or equal volumes of normal saline placebo daily for 3 days The primary outcomes at a corrected age of 18 months was a composite of death cerebral palsy cognitive delay deafness or blindness Secondary long-term outcomes were hydrocephalus necessitating the placement of a shunt seizure disorder and microcephaly Secondary short-term outcomes were patent ductus arteriosus pulmonary hemorrhage chronic lung disease cranial ultrasonographic abnormalities nectrotizing enterocolitis and retinopathy Infants were evaluated in follow-up at 18-22 months corrected age
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 |
|---|---|---|---|
| M01RR000070 | NIH | Medical Research Council of Canada | httpsreporternihgovquickSearchM01RR000070 |
| U10HD034216 | NIH | None | None |
| U10HD027904 | NIH | None | None |
| U10HD021364 | NIH | None | None |
| U10HD027851 | NIH | None | None |
| U10HD021397 | NIH | None | None |
| U10HD027881 | NIH | None | None |
| U10HD027880 | NIH | None | None |
| U10HD021373 | NIH | None | None |
| U10HD021385 | NIH | None | None |
| MT-13288 | OTHER_GRANT | None | None |
| M01RR000997 | NIH | None | None |