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

Premature Birth Clinical Trial

Official title:

Skin-to-skin After Delivery in Preterm Infants Born at 28-32 Weeks of Gestation. A Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02024854
• Other study ID #: KC28-32
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2014
• Est. completion date: December 2025

Study information

• Verified date: January 2023
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 108
• Est. completion date: December 2025
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Weeks to 32 Weeks

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Infants who need immediate medical interventions

Related Conditions & MeSH terms

• Premature Birth

Intervention

Behavioral:
• skin-to-skin

• standard care

Locations

Country	Name	City	State
Canada	IWK Health Centre	Halifax
Norway	Nyfødt intensiv, Drammen sykehus	Drammen
Norway	Nyfødt intensiv, Sørlandet Sykehus	Kristiansand
Norway	NICU St Olavs Hospital	Trondheim

Sponsors (5)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Drammen sykehus, IWK Health Centre, Sorlandet Hospital HF, St. Olavs Hospital

Countries where clinical trial is conducted

Canada,  Norway, 

References & Publications (1)

Kristoffersen L, Stoen R, Rygh H, Sognnaes M, Follestad T, Mohn HS, Nissen I, Bergseng H. Early skin-to-skin contact or incubator for very preterm infants: study protocol for a randomized controlled trial. Trials. 2016 Dec 12;17(1):593. doi: 10.1186/s13063-016-1730-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cognitive scorer at two years corrected age	measured by Bayley Scales of Infant Development Third Edition (BSID III)	2 year
Secondary	change in heart rate		24 hours
Secondary	change in body temperature		24 hours
Secondary	change in respiration frequency		24 hours
Secondary	change in blood glucose		24 hours
Secondary	general movements (GM) at 3 months corrected age	assessed with the General Movement Assessment (GMA)	3 months
Secondary	Nutrition	based on a Norwegian questionnaire, based on a Norwegian national survey from The Norwegian Directorate of Health.	1 year
Secondary	Social/emotional competence at three months corrected age	measured with the Ages and Stages Questionnaire: Social Emotional (ASQ:SE)	3 months
Secondary	Social/emotional competence at two years corrected age	measured with the Ages and Stages Questionnaire: Social Emotional (ASQ:SE)	1 year
Secondary	Social/emotional competence at two years corrected age	measured with the Ages and Stages Questionnaire: Social Emotional (ASQ:SE)	2 years
Secondary	Developmental skills at two years corrected age	measured with the Ages and Stages Questionnaire: (ASQ)	1 year
Secondary	Developmental skills at two years corrected age	measured with the Ages and Stages Questionnaire: (ASQ)	2 years
Secondary	Maternal anxiety	measured with State-Trait Anxiety Inventory (STAI)	at discharge from hospital
Secondary	Maternal anxiety	measured with State-Trait Anxiety Inventory (STAI)	3 months
Secondary	Maternal anxiety	measured with State-Trait Anxiety Inventory (STAI)	2 years
Secondary	Child Behaviour	Measured with Child Behaviour Checklist	5 year