Skin-to-skin After Delivery in Preterm Infants Born at 28-32 Weeks of Gestation

Norwegian University of Science and Technology

Status: Active, not recruiting

Conditions: Premature Birth

Treatments: Behavioral: skin-to-skin; Behavioral: standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT02024854

KC28-32

Details and patient eligibility

About

The aim of the study is to investigate physiological response, social/emotional response and general movements in preterm infants when they are given skin-to-skin contact with the mother (intervention) or standard care (incubator) right after delivery. Preterm infants will be randomized to either intervention or standard care group. Data on body temperature, blood glucose, hart rate, respiration rate and oxygen saturation will be obtained. In addition the infant will be video-recorded during the first 24 hours and at three months of age for analysis of the general movements.

Full description

Power calculations are based on a difference in Bayley Scale of Infant Development III, cognitive scale at two years corrected age of about 7,5 mean score =0.5 SD (α=0,05, β=0.80). Based on this analysis, 64 preterm infants are needed in each group to yield statistic significance. Allowing for withdrawals, the sample size is set to 68 in each group.

Enrollment: 108 patients

Sex: All

Ages: 28 to 32 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Preterm infants at 28-32 weeks of gestation (born 12-8 weeks before term)

Exclusion criteria

• Infants who need immediate medical interventions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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108 participants in 2 patient groups

skin-to-skin

Experimental group

Description:

immediately after birth the baby is laid on mother's chest for as long as justifiable medically to max 2 hours.

Treatment:

Behavioral: skin-to-skin

standard care

Active Comparator group

Description:

after birth the baby is transferred to the neonatal intensive care unit

Treatment:

Behavioral: standard care