| Methods |
Single centre, randomized controlled trial without the use of a placebo.
13‐ month study period (dates not given), USA.
I. Blinding of randomization:
‐unclear
II. Blinding of intervention: no
III. Complete follow‐up:
‐ no (see notes)
IV. Blind outcome assessment: no |
| Participants |
70 VLBW (<1500 g) preterm infant with severe respiratory distress (more than 50% FiO2 and UAC in place) and left to right shunting through the PDA determined by contrast echocardiogram on the first day of life.
BW (mean +/‐ SD) 975 +/‐ 234 g, GA 27 +/‐ 2.3 wk (maintenance group) versus BW 972+/‐ 245 g, GA 27 +/‐ 2.2 wk (non‐maintenance group).
All infants entered the study within the first 24 hours of life and most infants did not have PDA symptomatology at this time.
Exclusion criteria: serum creatinine > 2 mg/dl, oliguria, bleeding diathesis, indirect bilirubin > 12 mg/dl, platelet count < 60,000/uL, any congenital anomalies. |
| Interventions |
Initially, all infants received 2 oral doses of indomethacin at a dose of 0.15 mg/kg given 12 hours apart. Prolonged course: oral indomethacin for 5 additional days (0.1 mg/kg) (n=34).
Short course: no additional indomethacin (n=36). A follow‐up contrast echocardiogram was done within 24 hours after receiving the first 2 doses of indomethacin. Each of the infants with an initially closed PDA was followed for ductal reopening. Infants were followed clinically daily by one of the investigators (not blinded) until discharge for ductal re‐opening signs. Cardiology follow ‐up (blinded) with echocardiography (left atrial size) was done if left to right shunting through the ductus was suspected. |
| Outcomes |
Primary: re‐opening of PDA
Other: length of oxygen requirement, NEC, IVH, VP shunt placement, mortality, length of stay |
| Notes |
Oral administration Looked at re‐opening rates once PDA was shown to be closed after the first 2 doses;
contrast echocardiogram was not done to assess closure rates after the intervention (umbilical catheter not longer clinically indicated).
Contrast echocardiograms (Doppler not available during study period).
Only the infants who had their ductus closed by contrast echocardiogram after the first 2 doses of indomethacin were followed for ductal reopening (there are no data concerning the infants whose ductus did not close at this time).
Indomethacin was used in a near prophylactic manner, i.e. echocardiograms were performed at 24 hours of life, when ductal patency would be considered to be physiological. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
