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

• Sponsor: Norwegian University of Science and Technology (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02024854
• Collaborator: St. Olavs Hospital (Other), Drammen sykehus (Other), Sorlandet Hospital HF (Other), IWK Health Centre (Other)
• Enrollment: 136
• Locations: 4
• Arms: 2
• Anticipated Duration (Months): 106
• Patients Per Site: 34
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Premature Birth	Behavioral: skin-to-skin; Behavioral: standard care	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 136 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Skin-to-skin After Delivery in Preterm Infants Born at 28-32 Weeks of Gestation. A Randomized Controlled Trial
• Actual Study Start Date: Feb 1, 2014
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: skin-to-skin immediately after birth the baby is laid on mother's chest for as long as justifiable medically to max 2 hours.	Behavioral: skin-to-skin
Active Comparator: standard care after birth the baby is transferred to the neonatal intensive care unit	Behavioral: standard care

Outcome Measures

Primary Outcome Measures

1. cognitive scorer at two years corrected age [2 year]

   measured by Bayley Scales of Infant Development Third Edition (BSID III)

Secondary Outcome Measures

1. change in heart rate [24 hours]

2. change in body temperature [24 hours]

3. change in respiration frequency [24 hours]

4. change in blood glucose [24 hours]

5. general movements (GM) at 3 months corrected age [3 months]

   assessed with the General Movement Assessment (GMA)

6. Nutrition [1 year]

   based on a Norwegian questionnaire, based on a Norwegian national survey from The Norwegian Directorate of Health.

7. Social/emotional competence at three months corrected age [3 months]

   measured with the Ages and Stages Questionnaire: Social Emotional (ASQ:SE)

8. Social/emotional competence at two years corrected age [1 year]

   measured with the Ages and Stages Questionnaire: Social Emotional (ASQ:SE)

9. Social/emotional competence at two years corrected age [2 years]

   measured with the Ages and Stages Questionnaire: Social Emotional (ASQ:SE)

10. Developmental skills at two years corrected age [1 year]

    measured with the Ages and Stages Questionnaire: (ASQ)

11. Developmental skills at two years corrected age [2 years]

    measured with the Ages and Stages Questionnaire: (ASQ)

12. Maternal anxiety [at discharge from hospital]

    measured with State-Trait Anxiety Inventory (STAI)

13. Maternal anxiety [3 months]

    measured with State-Trait Anxiety Inventory (STAI)

14. Maternal anxiety [2 years]

    measured with State-Trait Anxiety Inventory (STAI)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 28 Weeks to 32 Weeks
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• Infants who need immediate medical interventions

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IWK Health Centre	Halifax		Canada
2	Nyfødt intensiv, Drammen sykehus	Drammen		Norway
3	Nyfødt intensiv, Sørlandet Sykehus	Kristiansand		Norway
4	NICU St Olavs Hospital	Trondheim		Norway

Sponsors and Collaborators

• Norwegian University of Science and Technology
• St. Olavs Hospital
• Drammen sykehus
• Sorlandet Hospital HF
• IWK Health Centre

Investigators

• Study Director: Håkon Bergseng, md phd, Norwegian University of Science and Technology

Study Documents (Full-Text)

None provided.

More Information

Publications

• Kristoffersen L, Støen R, Rygh H, Sognnæs 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.

• Responsible Party: Norwegian University of Science and Technology
• ClinicalTrials.gov Identifier: NCT02024854
• Other Study ID Numbers: KC28-32
• First Posted: Dec 31, 2013
• Last Update Posted: Mar 15, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Norwegian University of Science and Technology: Kangaroo-Mother Care Method; Stress, Physiological
• Additional relevant MeSH terms: Premature Birth

Study Results

No Results Posted as of Mar 15, 2022