Data extraction form for studies included in the review and meta-analysis
| General information | ||
| Data form completed (dd/mm/yyyy) | ||
| Name/ID of data extractor | ||
| Study ID Author last name_study year | ||
| Study citation | ||
| Year of study conduct | ||
| Country of study conduct | ||
| Funding source | ||
| Conflict of interest | ||
| Characteristics of included studies | ||
| Methods | ||
| Aim of study | ||
| Study design | ||
| Method of randomisation | ||
| Start date | ||
| End date | ||
| Participant characteristics | ||
| Population description | ||
| Setting | ||
| Inclusion criteria | ||
| Exclusion criteria | ||
| Number of participants | ||
| Baseline imbalances* | ||
| Birth weight (grams) | ||
| Gestational age (weeks) | ||
| Postnatal age (hours, days or weeks) | ||
| Underlying condition/cause of hypotension | ||
| Comorbidities | ||
| Concurrent medications | ||
| Intervention/exposure characteristics | ||
| Hydrocortisone details | ||
| Timing of administration Primary or rescue therapy or other | ||
| Dosing details Initial dose (mg/kg) Maintenance dose (mg/kg/day) Treatment interval (hours) Treatment length (hours) Cumulative dose (mg/kg) | ||
| Control/comparator details | ||
| Pharmacotherapy Dopamine Dobutamine Epinephrine Norepinephrine Milrinone Vasopressin Placebo Other | ||
| Outcomes details† | ||
| Primary outcomes | ||
| Improvement Yes or No | If Yes, Timing‡ | |
| SBP | ||
| DBP | ||
| MBP | ||
| Urine output | ||
| Inotropic support | ||
| Serum lactate | ||
| Mortality | Death in the ICU Yes or No | |
| Secondary outcomes§ | ||
| Major neurosensory disability | ||
| Moderate to severe motor impairment | ||
| Moderate to severe cognitive impairment | ||
| Cerebral palsy | ||
| Visual impairment | ||
| Hearing impairment | ||
| BPD | ||
| Occurrence of adverse events | ||
| Gastrointestinal events | ||
| Hyperglycemia | ||
| Hypertension | ||
| Hospital acquired infection | ||
*Statistically significant (p<0.05) differences in baseline characteristics between intervention and control or exposed and unexposed participant groups, as reported by the study authors.
†The primary and secondary outcome variables are defined as per the primary studies.
‡Within first 12 hours of treatment initiation.
§For all secondary outcome variables, the number or % in exposed vs unexposed groups; attributed to hydrocortisone will be applied for the analysis.
BPD, bronchopulmonary dysplasia; DBP, diastolic blood pressure; ICU, intensive care unit; MBP, mean blood pressure; SBP, systolic blood pressure.