Rojas 2003.

Methods	Randomized controlled trial conducted in Connecticut, United States
Participants	Number of infants: 60 Inclusion criteria: very low birthweight infants (< 1501 g) with gestational age ≤ 32 weeks, with minimal ventilatory support or extubated on nasal continuous positive airway pressure or nasal canula, with hemodynamic stability Exclusion criteria: mother's age < 18 years, history of illicit drug use during pregnancy, clinical evidence of perinatal asphyxia, potential transfer within the first month after birth, presence of a major congenital anomaly, planned adoption, grade III or IV intraventricular hemorrhage, fetal growth restriction, suspected sepsis Infant stabilization status at trial entry: stabilized Infant age and weight at trial entry: Mean age at trial entry was 19 days, and mean weight was 1021 ± 268 g and 1002 ± 219 g for KMC and control infants, respectively
Interventions	KMC group: Infants were held in a prone semi upright position at approximately a 45° angle, in direct SSC with the parent's chest. Infants wore only a diaper, and their backs were covered with a blanket. Mean duration of KMC was 1.3 ± 0.7 hours per day for an average of 15 ± 16 days (n = 33) Control group: Parents removed their infants from the incubator and held them in their arms in supine position with eye‐to‐eye contact. Infants wore diapers and T‐shirts and were wrapped in a blanket (n = 27) Level of care: NICU of a hospital Human resources: doctors and nurses Criteria for infant discharge from the hospital: unreported Scheme for follow‐up of infants after discharge: not performed
Outcomes	Mortality at discharge; sepsis; necrotizing enterocolitis; intraventricular hemorrhage; weight, head circumference, and length at discharge; rate of weight gain and head circumference growth; total weight gain and head circumference growth; breastfeeding at discharge; hospital stay
Notes	19% of LBW infants met eligibility criteria
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random number table
Allocation concealment (selection bias)	Low risk	Numbered sealed opaque envelopes
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding of participants: no/unfeasible; blinding of clinical staff: no/unfeasible
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Unreported
Incomplete outcome data (attrition bias) All outcomes	Low risk	No infants lost to follow‐up
Selective reporting (reporting bias)	Low risk	All outcomes stated in Methods section adequately reported or explained in Results
Other bias	Low risk	Other biases not identified