108 Participants Needed

Skin-to-Skin Contact for Premature Birth

Recruiting at 3 trial locations
LM
HB
Overseen ByHåkon Bergseng, md phd
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Norwegian University of Science and Technology
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

HB

Håkon Bergseng, md phd

Principal Investigator

Norwegian University of Science and Technology

Are You a Good Fit for This Trial?

This trial is for preterm infants born between 28-32 weeks of gestation. It's not suitable for those needing immediate medical interventions after birth.

Inclusion Criteria

My baby was born between 28 and 32 weeks of pregnancy.

Exclusion Criteria

My infant requires immediate medical care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Preterm infants receive skin-to-skin contact with the mother or standard care in an incubator immediately after birth

Up to 2 hours
1 visit (in-person)

Initial Follow-up

Infants are monitored for physiological and social/emotional responses, including video recording during the first 24 hours and at three months of age

3 months
Multiple visits (in-person)

Long-term Follow-up

Assessment of cognitive development, social/emotional competence, and other developmental skills at one and two years corrected age

2 years

What Are the Treatments Tested in This Trial?

Interventions

  • skin-to-skin
  • standard care
Trial Overview The study compares the effects of skin-to-skin contact with standard care in an incubator on preterm infants' physiological and emotional responses, as well as their general movements.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: skin-to-skinExperimental Treatment1 Intervention
Group II: standard careActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Norwegian University of Science and Technology

Lead Sponsor

Trials
673
Recruited
2,187,000+

Drammen sykehus

Collaborator

Trials
15
Recruited
101,000+

IWK Health Centre

Collaborator

Trials
131
Recruited
112,000+

Sorlandet Hospital HF

Collaborator

Trials
122
Recruited
92,100+

St. Olavs Hospital

Collaborator

Trials
549
Recruited
309,000+
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