| Methods |
Open, 2 center randomized trial.
Masking of allocation: No
Masking of intervention: No
Complete follow‐up: Yes |
| Participants |
32 newborns with congenital diaphragmatic hernia. Infants less than 34 weeks, 2 kilograms or older than 12 hours were excluded. 14 infants were randomized to immediate repair, 18 to delayed repair. All patients developed respiratory distress within 3 hours of birth. |
| Interventions |
Infants either underwent surgical repair within the first 6 hours of admission or after 96 hours when there was no evidence of pulmonary hypertension |
| Outcomes |
Primary outcome: Survival to hospital discharge.
Secondary outcomes: Use of ECMO, procedure used, duration of hospitalization for survivors, and complications. |
| Notes |
2 of the initial 14 patients in the early group were placed on ECMO before repair, and were excluded. Outcome data being requested from investigators. 75% of included patients received ECMO. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
High risk |
Masking of allocation: No |
| Blinding?
All outcomes |
High risk |
Masking of intervention: No |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Complete follow‐up: Yes |
