Comparing two skin-to-skin contact techniques for preterm infants
Comparison of Two Different Skin-to-skin Contact Techniques: Sustained Diagonal Flexion (SDF) With Sling Versus Traditional Prone Position With Headband During Skin-to-skin Care Session
NA · Erasme University Hospital · NCT06154148
This study is testing two different ways to hold preterm babies skin-to-skin to see which method helps both the babies and their parents feel better and more connected.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 24 Hours to 4 Days |
| Sex | All |
| Sponsor | Erasme University Hospital (other) |
| Locations | 1 site (Brussels, Anderlecht) |
| Trial ID | NCT06154148 on ClinicalTrials.gov |
What this trial studies
This study compares two methods of skin-to-skin positioning for preterm infants: the traditional prone position and a new technique called sustained diagonal flexion (SDF). It is a prospective, controlled, randomized trial that will recruit 80 parent-infant dyads, assigning them to one of the two positioning methods. The study aims to evaluate the effects of these techniques on skin-to-skin contact duration, cardiorespiratory stability, parental stress, and overall satisfaction. Data will be collected on various outcomes, including breastfeeding continuation after discharge and the risk of postpartum depression in mothers.
Who should consider this trial
Good fit: Ideal candidates are premature infants born between 27 and 34 weeks of gestational age, aged between 24 hours and 4 days.
Not a fit: Patients with severe neurological or medical conditions, or those requiring surgery during their neonatal stay, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the bonding experience and health outcomes for preterm infants and their parents.
How similar studies have performed: While the traditional prone position is well-established, the sustained diagonal flexion method is a novel approach that has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Premature infant born between 27 and 34 weeks of gestational age * Aged between 24 hours and maximum 4 days at the beginning of the study * Approval from the neonatologist in charge of the patient to participate in the study * Informed consent of the parents to participate in the study * At least one of the two parents must have a good knowledge of French. Exclusion Criteria: * Infant with severe secondary neurological or medical conditions, e.g., neurological deficits due to vascular hemorrhage (grade III or IV) * Infant or parent who requires or has required surgery during their neonatal stay * Triplets * Parent who suffers from a physical disability or severe psychological illness, a psychosocial situation that does not allow skin-to-skin care * Infant with an arterial line
Where this trial is running
Brussels, Anderlecht
- Neonatal Unit Hopital Erasme — Brussels, Anderlecht, Belgium (RECRUITING)
Study contacts
- Principal investigator: Dorottya Kelen — Head of Neonatal Unit
- Study coordinator: Dorottya Kelen, MD
- Email: dorottya.kelen@erasme.ulb.ac.be
- Phone: 025553430
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Skin-to-skin, Preterm Birth, Kangaroo Care, Sustained diagonal flexion, skin-to-skin contact time, Joint mobility and muscular tension assessment, Preterm, Family centered care