NCT05709392 Preterm DElayed Cord Clamping and Early Skin-to-Skin Contact: PreDECESS
| NCT ID | NCT05709392 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ostergotland County Council, Sweden |
| Condition | Bonding |
| Study Type | INTERVENTIONAL |
| Enrollment | 126 participants |
| Start Date | 2022-12-12 |
| Primary Completion | 2028-12-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 126 participants in total. It began in 2022-12-12 with a primary completion date of 2028-12-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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?
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05709392 clinical trial?
This trial is open to participants of all sexes, aged 30 Weeks or older, up to 34 Weeks, studying Bonding. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05709392 currently recruiting?
Yes, NCT05709392 is actively recruiting participants. Contact the research team at thomas.abrahamsson@liu.se for enrollment information.
Where is the NCT05709392 trial being conducted?
This trial is being conducted at Linköping, Sweden.
Who is sponsoring the NCT05709392 clinical trial?
NCT05709392 is sponsored by Ostergotland County Council, Sweden. The trial plans to enroll 126 participants.