Methods |
Randomised trial with concurrent eligible patients outside of the RCT. The non‐RCT patients were not in the RCT because of parental refusal (101), obstetrician request (35) or late arrival of the team (27). Infants born through thin meconium, after an otherwise low‐risk pregnancy. Outcomes were assessed by respiratory therapists. No losses to follow up. |
Data |
Characteristics of non‐RCT patients presented and compared to RCT patients who received the same treatment. RCT infants under observation were 46 boys and 46 girls. Non‐ RCT observational infants were 26 boys and 36 girls. |
Comparisons |
Two RCT arms, each of them were compared with similarly treated eligible non‐RCT patients. Experimental: observation alone, no intubation. Control: intubation, which is 'routine meconium management'. |
Outcomes |
Clinical outcomes were assessed in all the infants. Infants were followed for the duration of the hospital stay. Main outcome was number of respiratory symptoms. |
Notes |
The two treatments were not statistically significantly different. |