Methods

Concealed at randomization ‐ yes (computer generated randomization code ‐ placed in sealed envelopes); Blinding of intervention ‐ yes;
Complete follow‐up ‐ Unclear (three withdrawals, groups not specified)
Blinding of outcome assessment ‐ yes.

Participants

21 preterm infants (< 35 weeks gestation) with apnea (apnea > 20 sec with > 25% fall in heart rate and 10% fall in oxygen saturation or 5 torr or more fall in transcutaneous oxygen tension; 0.33 or more events per hr, = 8 or more per day) ; other causes of apnea excluded; similar mean gestational age (30.7 vs 31.3 weeks), birth weight (1441 vs 1303 gm), postnatal age at study entry (4.8 vs 2.9 days) and baseline apnea rate (0.94 vs 0.70/hr).

Interventions

Doxapram intravenously; 3 mg/kg load and 1.5 mg/kg/hr vs saline placebo.

Outcomes

Apnea at 48 hours (failure of rate of events to fall below 0.33/hr or use of mechanical ventilation); use of IPPV.

Notes

Cross over design and simultaneous comparison with doxapram ‐ not evaluated here.
Additional treatment with CPAP allowed ‐ no information on who received this (author clarification requested).

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Concealed at randomization

Allocation concealment (selection bias)

Low risk

Adequate

Blinding (performance bias and detection bias)
All outcomes

Low risk

Blinding of intervention and outcome assessment

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Three infants (9.7%) withdrawn, groups not specified

Selective reporting (reporting bias)

Low risk

Other bias

Low risk