Actively Recruiting

Phase Not Applicable
Age: 30Weeks - 34Weeks
All Genders
ID05709392

Preterm DElayed Cord Clamping and Early Skin-to-Skin Contact for Premature Infants Born at 30+0 to 34+6 Weeks Gestation

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

126

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating a new method of caring for premature infants born between 30+0 and 34+6 weeks of gestation to see if delayed cord clamping combined with early skin-to-skin contact with a parent improves bonding. This prospective trial compares infants cared for traditionally with those cared for using the new method, aiming to understand effects on bonding, infant growth, neurological development, stress levels, breastfeeding, and parental mood. The study is conducted at multiple hospitals in Sweden and includes a qualitative component interviewing parents about their experiences. The new care method involves delaying cord clamping for more than three minutes and providing early skin-to-skin contact, even if the infant requires breathing support during this time. The traditional method involves early cord clamping and moving the infant to a resuscitation table away from the mother. Two groups of infants and their parents are enrolled: one before introducing the new method, and one after its introduction. The study collects data from clinical registers and performs various tests and questionnaires to assess outcomes. Participants will be evaluated through questionnaires on bonding and depression at multiple time points up to six months corrected age, and infant neurological development up to 48 months corrected age. Saliva tests measure stress hormones, and vital signs are monitored during the first hours after birth. Blood tests, placental blood measurements, and clinical data on respiratory support and complications are recorded. Parents' experiences are explored through interviews. Data analysis includes statistical tests to compare groups and adjust for factors like gestational age and birth weight.

CONDITIONS

Brief 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 30+0 and 34+6 weeks of gestation through vaginal delivery
  • Infants 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 not recommended (such as severe anemia or cardiac disease)
  • Infants with known malformations
  • Infants with moderate or severe asphyxia (APGAR score less than 4 at 5 minutes of age)
  • Cases where the physician deems delayed cord clamping inappropriate
  • No time recorded for cord clamping

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 3 hours after birth

Participants experience delayed cord clamping and early skin-to-skin contact with a parent immediately after birth. Infant vital signs and respiratory support needs are monitored closely for the first 3 hours after delivery.

Continuous monitoring during the first 3 hours after birth

Follow-up

Duration - Up to 48 months corrected age

Participants complete questionnaires about bonding, depression, and breastfeeding at multiple time points. Infant neurological development and stress markers are assessed up to 6 months corrected age, with additional neurological follow-up at 12 and 48 months corrected age.

Questionnaires and saliva tests at 1 week, 1 month, 2 months, 6 months, 12 months, and 48 months corrected age

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

K

Kari Axelsson, MD

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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