| Methods |
Double‐blind randomised controlled trial
Study location: neonatal intensive care units of Ain‐Shams Univeristy Hospital, Cairo, Egypt
Study period: March 2013 to March 2014 |
| Participants |
Preterm infants, PMA ≤ 33 weeks |
| Interventions |
20 infants received enteral rhG‐CSF, 20 received enteral rhEPO, 20 received both enteral rhG‐CSF and rhEPO, and 30 received distilled water as placebo. This regimen was started on the day the neonatologist chose to start feedings. Study drugs were given enterally. The daily dose of enteral rhG‐CSF and/or rhEPO was diluted in sterile distilled water and was kept in a separate opaque aliquot before administration through the orogastric/nasogastric tube with milk feedings for 7 days. rhEPO was given as 88 IU/kg (total dose 616 IU/kg ‐ high dose). The placebo group was given 1 mL of distilled water once daily. It is not clear whether all infants received the same volume/kg of drug for the 3 interventions. |
| Outcomes |
Death
NEC
Time to achieve full enteral feeding (days)
Duration of hospital stay (days) |
| Notes |
We included the outcome of Time to achieve full enteral feeding (days) under a separate comparison. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Randomisation sequence generated by computer |
| Allocation concealment (selection bias) |
Low risk |
Opaque sequentially numbered sealed envelopes |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Study drugs were kept in separate opaque aliquots before administration through the orogastric/nasogastric tube with milk feedings for 7 days. Control group was given 1 mL of distilled water (placebo). Placebo must have looked different from the opaque study drugs. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
See above. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
All randomised infants were accounted for. |
| Selective reporting (reporting bias) |
Low risk |
Trial was registered as NCT01441427, on September 18, 2011, before the trial started. No deviations from the protocol are apparent. |
| Other bias |
Low risk |
Appears free of other bias |
