Immediate Skin-To-Skin Care For Preterm Infants After Birth
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-30
SponsorMedical University of Graz
About this trial
The standard procedure in our centre for preterm neonates is to enable skin-to-skin (SSC) contact within 24 hours after birth. As early SSC immediately after birth might provide numerous positive effects for mothers and their preterm neonates, the objective of this study is to evaluate the feasibility, the safety and the effect of skin-to-skin contact immediately after birth in preterm neonates born with gestational age between 26+0 and 32+0 weeks.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Gestational age between 26+0 and 32+0 weeks
Written parental informed consent
Disqualifiers
No intention of full life support
Severe congenital malformation
Trial design
Design model
Parallel
Treatments tested in this trial
skin to skin care
Procedure/Surgeryskin to skin care of preterm infants with their parents immediately after birth
Standard Care (in control arm)
Procedure/Surgeryskin to skin care within 24 hours after birth
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Early skin-to-skin careExperimental treatment 1 intervention
Group B: Standard care groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
vital parameter: Heart rate
Time frame
during the first 2 hours after birth2
vital parameter: Oxygen saturation
in percent
Time frame
during the first 2 hours after birth3
vital parameter: blood pressure
systolic, diastolic and mean blood pressure
Time frame
during the first 2 hours after birth4
vital parameter: Temperature
Time frame
during the first 2 hours after birthSecondary outcomes
1
blood sugar
capillary blood sugar measured 1 hour after birth
Time frame
1 hour after birth2
FiO2 (Fraction of inspired oxygen)
Need of oxygen
Time frame
during first 2 hours after birthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov