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NCT Number: NCT02024854

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Premature Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Urogenital Diseases

Age range

28 week–32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IWK Health Centre, Halifax, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Infants who need immediate medical interventions

Treatment and study plan

Skin-to-skin

Behavioral

Standard Care

Behavioral

Primary outcomes

  1. cognitive scorer at two years corrected age

    Time frame: 2 year

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

Secondary outcomes

  1. change in heart rate

    Time frame: 24 hours

  2. change in body temperature

    Time frame: 24 hours

  3. change in respiration frequency

    Time frame: 24 hours

  4. change in blood glucose

    Time frame: 24 hours

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

    Time frame: 3 months

    assessed with the General Movement Assessment (GMA)

  6. Nutrition

    Time frame: 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

    Time frame: 3 months

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

  8. Social/emotional competence at two years corrected age

    Time frame: 1 year

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

  9. Social/emotional competence at two years corrected age

    Time frame: 2 years

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

  10. Developmental skills at two years corrected age

    Time frame: 1 year

    measured with the Ages and Stages Questionnaire: (ASQ)

  11. Developmental skills at two years corrected age

    Time frame: 2 years

    measured with the Ages and Stages Questionnaire: (ASQ)

  12. Maternal anxiety

    Time frame: at discharge from hospital

    measured with State-Trait Anxiety Inventory (STAI)

  13. Maternal anxiety

    Time frame: 3 months

    measured with State-Trait Anxiety Inventory (STAI)

  14. Maternal anxiety

    Time frame: 2 years

    measured with State-Trait Anxiety Inventory (STAI)

  15. Child Behaviour

    Time frame: 5 year

    Measured with Child Behaviour Checklist

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Drammen sykehus
  • IWK Health Centre
  • Sorlandet Hospital HF
  • St. Olavs Hospital

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2022
Study completion
2025
First posted
Dec 31, 2013
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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