Timing of PDA Closure and Respiratory Outcome in Premature Infants
Patent Ductus Arteriosus
About this trial
This is an interventional treatment trial for Patent Ductus Arteriosus focused on measuring Patent ductus arteriosus, Respiratory outcome
Eligibility Criteria
Inclusion Criteria:
- Inborn patients at JHS hospitals (admitted to the NICU at JMH within the first 72 hrs of age
- BW 500-1250 grams
- 23-32 wks gestational age
- > 1d but < 14d of age.
Exclusion Criteria:
- Major congenital malformations
- Proven sepsis (positive blood culture)
- Contraindications to the use of Ibuprofen or Indomethacin
- Terminal condition, not expected to survive beyond 48 h
- Infants born excessively SGA(3 S.D. below the mean for GA)
- Infants with initial PDA presentation that is hemodynamically significant
Sites / Locations
- Jackson Memorial Hospital/Holtz Children's Center
Arms of the Study
Arm 1
Arm 2
Experimental
Other
early ibuprofen
Late Ibuprofen expectant group (placebo)
Drug: Early ibuprofen IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to "early treatment" will receive blinded ibuprofen initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. This group will then be eligible to receive unblinded, open label ibuprofen for a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV.
Late ibuprofen expectant group (placebo): Ibuprofen schedule: At PDA diagnosis, infants randomized to "late expectant group" will receive blinded placebo. If hemo-dynamically significant PDA develops, infants now receive open label ibuprofen, initial dose of 10 mg/kg, then 2 doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Signs of a hemodynamically significant PDA: Signs of PDA + pulmonary hemorrhage alone or Signs of PDA + Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (due to PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV. Infants who had received placebo will ibuprofen for the first time (thus, "late" ibuprofen or expectant).