Skip to main content
. 2021 Oct 21;2021(10):CD001146. doi: 10.1002/14651858.CD001146.pub6

Watterberg 1999.

Study characteristics
Methods Two‐centre double‐blind randomised controlled trial
Participants Inclusion: 40 infants weighing between 500 grams and 999 grams who were AGA and needed mechanical ventilation, < 48 hours of age
Exclusions: maternal diabetes, congenital sepsis, SGA
Interventions Hydrocortisone 1.0 mg/kg/d every 12 hours for 9 days, 0.5 mg/kg/d for 3 days
Control infants were given an equal volume of normal saline
Outcomes Primary outcome
  • Survival without supplemental oxygen at 36 weeks' post conception


Secondary outcomes among survivors
  • BPD at 36 weeks

  • Duration of mechanical ventilation, > 40% oxygen, > 25% oxygen

  • Hospital stay

  • Weight and head circumference at 36 weeks

Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random allocation at each centre by constant block design with 4 participants per block to minimise bias over time. Separate randomisation tables were used for infants exposed to antenatal corticosteroids
Allocation concealment (selection bias) Low risk Allocation concealment: yes
Blinding of participants and personnel (performance bias)
All outcomes Low risk Blinding of intervention: yes
Blinding of outcome assessment (detection bias)
All outcomes Low risk Blinding of outcome measurement: yes
Incomplete outcome data (attrition bias)
All outcomes Low risk Complete follow‐up: yes
Selective reporting (reporting bias) Low risk All prespecified outcomes reported
Other bias Low risk None