| Methods |
Open, 2 center randomized trial.
Masking of allocation: No
Masking of intervention: No
Complete follow‐up: Yes |
| Participants |
54 newborns with congenital diaphragmatic hernia. 26 infants were randomized to early surgery, 28 to delayed surgery. No patients were excluded. Severity of symptoms was not well described. |
| Interventions |
Infants either underwent surgical repair within the first 4 hours of admission or after 24 hours when they were considered stable. |
| Outcomes |
Primary outcome: Survival to 6 months.
Secondary outcomes: duration of hospitalization. |
| Notes |
Average age at repair in the delayed group was 48 hours; 1 patient in early group was delayed for 11 days for genetic evaluation. 2 infants (4%) 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 |
