Preterm DElayed Cord Clamping and Early Skin-to-Skin Contact: PreDECESS
Recruiting now · Not applicable
Conditions studied: Bonding, Stress, Breastfeeding, Child Development, Adverse Events
In brief
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?
Key facts
- Study ID
- NCT05709392
- Run by
- Ostergotland County Council, Sweden
- People needed
- 126
- Starts
- 2022-12-12
- Expected to finish
- 2028-12-11
- Last updated by the study team
- 2023-02-02
Who can join
Age: 1 and older, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Infants born in gestational weeks 30+0-34+6 through vaginal delivery and admitted to neonatal ward in Sweden.
- Parents must be able to read Swedish.
You may not qualify if…
- Infants with known disease when an expanded blood volume is expected will be excluded as early cord clamping is recommended (severe anemia, cardiac disease etc).
- Infants with known malformations. Infants with severe or moderate asphyxia (defined as APGAR < 4 at 5 minutes of age).
- Infants where the physician in charge find it inappropriate with delayed cord clamping.
- No time for cord clamping has been registered.
Where it is running
- Crown Princess Victoria children´s hopsital — Linköping, Sweden (enrolling)
Full record on ClinicalTrials.gov
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