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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05709392 on ClinicalTrials.gov