Delivery Room Skin-to-skin Study

NCT01959737 | Completed

• 1 other identifier: 11-075
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

The first hours after birth are a sensitive period for promotion of optimal mother-child-interaction and secure attachment. Maternal sensitivity and responsivness are high in the first hours after birth due to high oxytocin levels. Developing optimal mother-child-interaction is more difficult for preterm mothers because mother and child are separated after birth and the preterm infant is not able to show strong signs to promote maternal sensitivity. We hypothesize that promoting skin-to-skin contact of VLBW infants and their mothers for 60 minutes within the first hours after birth improves mother-child-interaction at 5 to 6 months corrected age. We also hypothesize that reactivity of HPA axis and molecular patterns of stress signaling pathways differ in preterm infant with or without SSC after birth.

Conditions

Very Low Birthweight Infants; Mother Child Interaction; Preterm Infant

Keywords

reactivity of HPA axis

Outcome Measures

Primary Outcomes (1)

• Maternal sensitivity and responsiveness

  Maternal sensitivity and responsiveness are assessed with the "Mannheimer Method" for the analysis of mother child interaction. At the infants corrected age of 4 to 6 months a videotape of the mother changing the infants diapers and playing with the infant is used for analysis.

  4 to 6 moinths corrected age

Secondary Outcomes (2)

• Reactivity of HPA-axis

  36 to 40 weeks corrected age

• Molecular characterization of stress signaling pathways

  36 to 40 weeks corrected age

Study Arms (2)

visual contact

NO INTERVENTION

After initial assessment/stabilization of the VLBW infant, visual contact of mother and infant is permitted for 5 minutes.

skin-to-skin contact

EXPERIMENTAL

After initial stabilization mother and preterm infant are cared for skin-to-skin for 60 minuter. SSC is supervised by the attending neonatologist.

Procedure: skin-to.skin-contact

Interventions

skin-to.skin-contact PROCEDURE

Immediately after initial stabilization/ assessment of the VLBW infant, skin-to-skin contact of mother and infant is initiated and kept up for 60 minutes.

skin-to-skin contact

Eligibility Criteria

• Age: 10 Minutes - 60 Minutes
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Birthweight \<1500g, first child, informed consent

You may not qualify if:

• Multiples, malformation

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

University hospital of Cologne, Department of Neonatology

Cologne, Germany

Location

Related Publications (2)

• Mehler K, Wendrich D, Kissgen R, Roth B, Oberthuer A, Pillekamp F, Kribs A. Mothers seeing their VLBW infants within 3 h after birth are more likely to establish a secure attachment behavior: evidence of a sensitive period with preterm infants? J Perinatol. 2011 Jun;31(6):404-10. doi: 10.1038/jp.2010.139. Epub 2010 Dec 9.

  PMID: 21151007 BACKGROUND

• Trautmann-Villalba P, Heine E, Kribs A, Mehler K. Does early skin-to-skin contact have a long-term effect on the emotional and behavioral development of very preterm infants? Front Psychol. 2024 Nov 11;15:1484419. doi: 10.3389/fpsyg.2024.1484419. eCollection 2024.

  PMID: 39588126 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

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

Study Record Dates

• First Submitted: October 7, 2013
• First Posted: October 10, 2013
• Study Start: October 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: January 1, 2016
• Last Updated: June 26, 2018

Record last verified: 2018-06

Locations

DE (1)