| Methods |
Two‐center, randomized, controlled trial
I. Blinding of randomization ‐ can't tell
II. Blinding of intervention ‐ no
III. Complete follow‐up ‐ no
IV. Blinding of outcome measurements ‐ can't tell |
| Participants |
Study conducted in The Netherlands
32 infants (26‐35 weeks) with echocardiographic evidence of PDA were randomized.
18 infants, mean GA 29.4±0.5 weeks, >33 weeks 1, BW 1150±77 g, postnatal age 4±0.7 d (range 1‐14 d) were treated with continuous indomethacin.
14 infants, mean GA 30.8±0.5 weeks, >33 weeks 2, BW 1424±150 g, postnatal age 5±1.4 d (range 2‐22 d) were treated with bolus indomethacin. |
| Interventions |
Both groups received the same total amount of indomethacin (0.4mg/kg).
In the continuous group, indomethacin was administered during 36 h period at a dose of 0.011 mg/kg/h, intravenously.
In the bolus group, indomethacin was administered intravenously in three doses, rapidly within 30 seconds: Initial injection dose was 0.2 mg/kg and the subsequent doses were 0.1 mg/kg at 12 and 36 h after the initial dose. |
| Outcomes |
PDA closure
Reopening of PDA after completion of the allocated treatment
Neonatal mortality
IVH
NEC
Blood flow velocities: ICA, RA and SMA ‐ before indomethacin and at 10, 30, 60, 120 minutes and 12, 24, 36 and 48 hours after initiation of indomethacin therapy
Hemoglobin
Hematocrit
Platelet count
Serum sodium, potassium, BUN and creatinine
Blood gasses
Ventilator settings
Medications
Exposure to phototherapy
Urine output
HR
BP
Arterial oxygen saturation
tcpO2, tcpCO2 |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
Blinding of randomization ‐ can't tell |
| Blinding?
All outcomes |
High risk |
Blinding of intervention ‐ no
Blinding of outcome measurements ‐ can't tell |
| Incomplete outcome data addressed?
All outcomes |
High risk |
Complete follow‐up ‐ no |
