Actively Recruiting

Phase Not Applicable
Age: 30Weeks - 34Weeks
All Genders
NCT05709392

Preterm DElayed Cord Clamping and Early Skin-to-Skin Contact: PreDECESS

Led by Ostergotland County Council, Sweden · Updated on 2023-02-02

126

Participants Needed

1

Research Sites

313 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Preterm DElayed Cord Clamping and Early Skin-to-Skin Contact: PreDECESS

Who Can Participate

Age: 30Weeks - 34Weeks
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Infants born between gestational weeks 30+0 and 34+6 through vaginal delivery and admitted to a neonatal ward in Sweden.
  • Parents must be able to read Swedish.
Not Eligible

You will not qualify if you...

  • Infants with known diseases where expanded blood volume is expected, such as severe anemia or cardiac disease, as early cord clamping is recommended.
  • Infants with known malformations.
  • Infants with severe or moderate asphyxia, defined as APGAR score less than 4 at 5 minutes of age.
  • Infants for whom the physician in charge considers delayed cord clamping inappropriate.
  • No recorded time for cord clamping.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Crown Princess Victoria children´s hopsital

Linköping, Sweden, 58185

Actively Recruiting

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Research Team

T

Thomas Abrahamsson, MD,PhD

CONTACT

K

Kari Axelsson, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

0

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