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. 2023 Apr 11;2023(4):CD013873. doi: 10.1002/14651858.CD013873.pub2

Mohd 2021.

Study characteristics
Methods Study design: parallel RCT
Location: Malaysia
Setting: ICU (Hospital Universiti Sains Malaysia (USM), Kota Bharu, Kelantan)
Duration: June 2019 to August 2020
Participants Inclusion criteria: preterm infants ≤ 32 weeks' gestational age
Exclusion criteria: hydrops fetalis
Interventions High dose: loading dose 40 mg/kg/day and maintenance dose 20 mg/kg/day
Low dose: loading dose 20 mg/kg/day and maintenance dose 10 mg/kg/day
Outcomes Outcomes reported that are considered for this review:

  • frequency and number of days with apnea;

  • extubation failure;

  • duration of non‐invasive ventilation (e.g. Optiflow, Bipap, Duopap and CPAP);

  • duration of oxygen therapy (nasal prong oxygen);

  • chronic lung disease defined, as the need for oxygen at 36 weeks' post‐menstrual age;

  • tachycardia;

  • hypertension;

  • time to reach full enteral feeding;

  • weight gain;

  • length of hospital stay;

  • neonatal mortality;

  • necrotizing enterocolitis (NEC);

  • intraventricular hemorrhage (IVH);

  • periventricular leukomalacia (PVL);

  • retinopathy of prematurity (ROP);

  • number of infants for whom caffeine was withheld early because of suspected side effects; and

  • death before hospital discharge.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random sequence was generated by a researcher not involved in the recruitment
of patients and data collection, using blocks of variable sizes known only to the randomizer.
Allocation concealment (selection bias) Low risk Concealment of allocation was ensured by the use of opaque, sealed, and sequentially
numbered envelopes.
Blinding of participants and personnel (performance bias)
All outcomes Low risk Doctors, nursing staff, and family were blinded to the allocation.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Investigators were blinded to the allocation.
Incomplete outcome data (attrition bias)
All outcomes Low risk All infants received intended treatment until they exited the study. All included infants
were analyzed for primary outcome.
Selective reporting (reporting bias) Low risk The trial protocol is available at
www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377580. All pre‐specified
outcomes were reported in the manuscript.
Other bias Unclear risk More infants in the standard‐dose caffeine were intubated at the baseline (97% and 92% in the standard‐ and high‐dose caffeine groups, respectively) and needed surfactant (95% and 80% in the standard‐ and high‐dose groups, respectively)