Family-centered care for mothers and preterm infants
Evaluation of a Family-centred Care Intervention Based on Zero Separation and Couplet Care
This study tests a new approach that keeps mothers and their preterm babies together in the hospital to see if it helps them bond better and feel less stressed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 556 (estimated) |
| Sex | All |
| Sponsor | Copenhagen University Hospital, Hvidovre Academic / other |
| Locations | 1 site (Hvidovre) |
| Trial ID | NCT05236023 on ClinicalTrials.gov |
What this trial studies
This study evaluates a family-centered intervention that promotes zero separation and couplet care for mothers and their preterm infants in a neonatal intensive care unit. The approach allows mothers and infants to be admitted together, receiving care from neonatal nurses while minimizing separation. The study includes a quasi-experimental design, qualitative process evaluations, and a health economic assessment to determine the intervention's cost-effectiveness. The goal is to improve mother-infant bonding and reduce stress associated with separation during critical early life stages.
Who should consider this trial
Good fit: Ideal candidates include mothers with treatment-requiring conditions and infants born at or after 28 weeks of gestation who also require medical care.
Not a fit: Patients who are healthy mothers with infants in the NICU or those with severe conditions requiring adult intensive care may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance the emotional and physical well-being of both mothers and their preterm infants.
How similar studies have performed: Other studies have shown positive outcomes with family-centered care approaches, indicating potential success for this intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Mothers with a treatment-requiring condition such as preeclampsia, bleeding, psychological diagnoses, discontinued milk production and infection. * Infant from gestational age 28 weeks with a treatment-requiring condition such as respiratory distress syndrome (with respiratory support including mechanical ventilation), hyperbilirubinemia, infection, and low blood sugar. Exclusion Criteria: * Healthy mothers who does not need care and treatment, and has an infant admitted at NICU. * Mothers who are admitted at an adult intensive care unit due to severe sickness (severe preeclampsia with spasm, severe bleeding of 4-5 liter, and severe HELLP syndrome) - counting one-two mothers a year
Where this trial is running
Hvidovre
- Copenhagen University Hospital Hvidovre — Hvidovre, Denmark (Recruiting)
Study contacts
- Study coordinator: Michella Bjerregaard
- Email: michella.runge.kjoebeloev.bjerregaard.01@regionh.dk
- Phone: +45 24342904
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.