Preterm DElayed Cord Clamping and Early Skin-to-Skin Contact: PreDECESS
NCT05709392 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126
Last updated 2023-02-02
Summary
The PreDECESS trial is a prospective study where that will evaluate a new method taking care of premature infants in gestational weeks 30+0 to 34+6 at birth. The new method includes delayed cord clamping and early skin-to-skin contact with a parent. Two populations of infants with their parents will be compared. Infants taken care of in the traditional way before the new method is introduced, and infants taken care of with the new method when it is being introduced.
Primary question:
Does delayed cord clamping and early skin-to skin contact (SSC) lead to better bonding between parents and their infants?
Secondary questions:
Are there any potential adverse effects with delayed cord clamping and early skin-to skin contact (SSC)? Is there a difference in infants level of bilirubin, haemoglobin or proBNP? Is there a difference in infants growth? Is there a difference in infants neurological development? Is there a difference in infants and parents level of stress? Is there a difference in mothers production of breastmilk, frequency of breastfeeding or experience of breastfeeding? Is there a difference in parents mood? How do parents of preterm infants experience giving birth of their preterm baby before and after the introduction of the new method?
Conditions
- Bonding
- Stress
- Breastfeeding
- Child Development
- Adverse Events
Interventions
- PROCEDURE
-
Delayed cord clamping and early skin-to-skin contact
A new method for taking care of remature infants born in gestational weeks 30+0-34+6 will be introduced with delayed cord clamping and early skin-to-skin-contact with a parent. If the infant needs help with the breathing this can be given during the time when the cord is still intact.
Sponsors & Collaborators
-
Ostergotland County Council, Sweden
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 30 Weeks
- Max Age
- 34 Weeks
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-12-12
- Primary Completion
- 2028-12-11
- Completion
- 2028-12-11
Countries
- Sweden
Study Locations
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