Delivery Room Skin-to-skin Study

NCT ID: NCT01959737

Last Updated: 2018-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Very Low Birthweight Infants Mother Child Interaction Preterm Infant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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visual contact

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

Group Type NO_INTERVENTION

No interventions assigned to this group

skin-to-skin contact

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

Group Type EXPERIMENTAL

skin-to.skin-contact

Intervention Type 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.

Interventions

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skin-to.skin-contact

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Multiples, malformation
Minimum Eligible Age

10 Minutes

Maximum Eligible Age

60 Minutes

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cologne

OTHER

Sponsor Role lead

Responsible Party

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Katrin Mehler

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University hospital of Cologne, Department of Neonatology

Cologne, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 21151007 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39588126 (View on PubMed)

Other Identifiers

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11-075

Identifier Type: -

Identifier Source: org_study_id

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