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

NCT05709392 | Recruiting

• 1 other identifier: PreDECESS
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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?

Conditions

Bonding; Stress; Breastfeeding; Child Development; Adverse Events

Keywords

adverse events

Outcome Measures

Primary Outcomes (8)

• Bonding

  Bonding will be assessed with a self administrative instrument, Mother-to-Infant Bonding, Scale (S-MIBS), to parents. It consists of eight adjectives, each describing an emotion and parents will answer how well the adjectives correlated to how they felt for the last 7 days on a four-point scale ranging from 0 to 3. The maximum score is 24, with higher values indicating more bonding challenges.

  Parents will answer the questionnaires 1 week after delivery.

• Bonding

  Bonding will be assessed with a self administrative instrument, Postpartum Bonding Questionnaire (PBQ), to parents. \]. It consists of 25 statements about parents feelings, where parents answer how well statement applies to them on a six-point scales ranging from 0 to 5, with higher values indicating more problems.

  Parents will answer the questionnaires 1 week after delivery.

• Bonding

  Bonding will be assessed with a self administrative instrument, Mother-to-Infant Bonding Scale (S-MIBS), to parents. It consists of eight adjectives, each describing an emotion and parents will answer how well the adjectives correlated to how they felt for the last 7 days on a four-point scale ranging from 0 to 3. The maximum score is 24, with higher values indicating more bonding challenges.

  Parents will answer the questionnaires 1 month after delivery.

• Bonding

  Bonding will be assessed with a self administrative instrument, Postpartum Bonding Questionnaire (PBQ), to parents. It consist of 25 statements about parents feelings, where parents answer how well statement applies to them on a six-point scales ranging from 0 to 5, with higher values indicating more problems.

  Parents will answer the questionnaires 1 month after delivery.

• Bonding

  Bonding will be assessed with a self administrative instrument, Mother-to-Infant Bonding Scale (S-MIBS), to parents. It consists of eight adjectives, each describing an emotion and parents will answer how well the adjectives correlated to how they felt for the last 7 days on a four-point scale ranging from 0 to 3. The maximum score is 24, with higher values indicating more bonding challenges.

  Parents will answer the questionnaires when the infants are 2 months old corrected age.

• Bonding

  Bonding will be assessed with a self administrative instrument, Postpartum Bonding Questionnaire (PBQ), to parents. It consists of 25 statements about parents feelings, where parents answer how well statement applies to them on a six-point scales ranging from 0 to 5, with higher values indicating more problems.

  Parents will answer the questionnaires when the infants are 2 months old corrected age.

• Bonding

  Bonding will be assessed with self a administrative instrument, Mother-to-Infant Bonding Scale (S-MIBS), to parents.It consists of eight adjectives, each describing an emotion and parents will answer how well the adjectives correlated to how they felt for the last 7 days on a four-point scale ranging from 0 to 3. The maximum score is 24, with higher values indicating more bonding challenges.

  Parents will answer the questionnaires when the infants are 6 months old corrected age.

• Bonding

  Bonding will be assessed with self a administrative instrument, Postpartum Bonding Questionnaire (PBQ), to parents. It consists of 25 statements about parents feelings, where parents answer how well statement applies to them on a six-point scales ranging from 0 to 5, with higher values indicating more problems.

  Parents will answer the questionnaires when the infants are 6 months old corrected age.

Secondary Outcomes (43)

• Cortisol in saliva

  The saliva tests will be done when the infants are 7 ± 1 days, and 1 month corrected age.

• Oxytocin in saliva

  The oxytocin tests will be taken when the infants are 8 ± 1 days old.

• Depression in parents

  Parents will answer the questionnaire 1 week and 1 month after delivery and when the infants are 2 and 6 months old corrected age.

• Experience of breastfeeding

  Mothers will answer the questionnaire when the infants are 2 and 6 months old corrected age.

• Breastmilk production

  Mothers will answer the questionnaire when the infants are 2 and 6 months old corrected age. Data from the Swedish Quality Register will be collected after all the infants have been included in the study.

Interventions

Delayed cord clamping and early skin-to-skin contact PROCEDURE

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.

Eligibility Criteria

• Age: 30 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Ostergotland County Council, Sweden: lead

Study Sites (1)

Crown Princess Victoria children´s hopsital

Linköping, 58185, Sweden

RECRUITING

MeSH Terms

Conditions

Breast Feeding

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Thomas Abrahamsson, MD,PhD

CONTACT

+46709566815; thomas.abrahamsson@liu.se

Kari Axelsson, MD

CONTACT

kari.axelsson@regionostergotland.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Comparison of a cohort of premature infants born in gestational week 30+0 till 34+6 taken care of at birth in the traditional way and another cohort of infants taken care of with a new method. The study will be prospective and the control group will be enrolled first before and the active group after the new method has been introduced.

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: February 2, 2023
• Study Start: December 12, 2022
• Primary Completion (Estimated): December 11, 2028
• Study Completion (Estimated): December 11, 2028
• Last Updated: February 2, 2023

Record last verified: 2023-01

Locations

SE (1)