Clinical trial NCT05975203: Continuous Delivery Room Skin-to-skin-study for Moderate and Late Preterm Infants
Official title: Continuous Delivery Room Skin-to-skin-study for Moderate and Late Preterm Infants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Preterm Birth
Mother-Infant Interaction
Infant Development
Keywords: preterm behavioral epigenetics
skin-to-skin contact
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2023-08-03
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this randomized controlled trial is to compare the effect of direct skin-to-skin contact in moderate and late preterm infants. The main questions it aims to answer are:

* does skin-to-skin contact in moderate and late preterm infants influence gene expression in the stress signaling pathway?
* does skin-to-skin contact in moderate and late preterm infants improve the short- and long-term outcome?

Participants will either get immediate separation after vaginal birth or receive immediate skin-to-skin contact. Researchers will compare these two groups to answer the proposed questions.

Detailed description: The planned study investigates prospectively the effect of early intervention (skin-to-skin contact in the delivery room) in moderate and late preterm infants on neonatal programming by determining gene expression in the stress signaling pathway. The working hypothesis of our project is that the intervention will affect gene expression in a way that subsequently leads to better long-term psycho-social and neurological development of these preterm infants. The study aims to improve the understanding of the correlation of behavioral and epigenetic parameters and prove the underlying hypothesis of a novel mechanistic link between immediate skin-to-skin contact in the delivery room and life-long stress tolerance.

Eligibility criteria: Inclusion Criteria:

* preterm birth between gestational age of 32 0/7 and 36 6/7 weeks
* vaginal delivery
* singleton
* informed consent before birth

Exclusion Criteria:

* malformations or syndromes of the infant
* resuscitation of the infant
* maternal psychological or severe physical illness
* lack of German language skills

Primary outcomes:
measure: gene expression in candidate genes of the stress signalling pathway
timeFrame: 36 to 72 hours after birth
measure: gene expression in candidate genes of the stress signalling pathway
timeFrame: corrected 6 months of age
measure: gene expression in candidate genes of the stress signalling pathway
timeFrame: corrected 24 months of age
Secondary outcomes:
measure: mother-child-interaction
timeFrame: corrected 6 months of age
measure: General Movements
timeFrame: corrected 3 months of age
measure: maternal depression
timeFrame: at inpatient discharge (assessed from 3 to 60 days of life), corrected 6 and 24 months of age
measure: social support
timeFrame: at inpatient discharge (assessed from 3 to 60 days of life), corrected 24 months of age
measure: socio-economic status
timeFrame: at inpatient discharge (assessed from 3 to 60 days of life)
measure: breastfeeding
timeFrame: at inpatient discharge (assessed from 3 to 60 days of life) and corrected six months of age
measure: impact of event scale
timeFrame: corrected 6 months of age
measure: Parental Bonding
timeFrame: corrected 6 and 24 months of age
measure: Parental Stress
timeFrame: corrected 6 and 24 months of age
measure: reactivity of hypothalamic-pituitary-adrenal-axis
timeFrame: 36 to 72 hours after birth and corrected 24 months of age
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University hospital of Cologne, Department of Neonatology
state: Northrhine-westfalia
Study officials:
affiliation: University of Cologne
name: Katrin Mehler, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mehler K, Hucklenbruch-Rother E, Trautmann-Villalba P, Becker I, Roth B, Kribs A. Delivery room skin-to-skin contact for preterm infants-A randomized clinical trial. Acta Paediatr. 2020 Mar;109(3):518-526. doi: 10.1111/apa.14975. Epub 2019 Sep 16.
citation: Hucklenbruch-Rother E, Vohlen C, Mehdiani N, Keller T, Roth B, Kribs A, Mehler K. Delivery room skin-to-skin contact in preterm infants affects long-term expression of stress response genes. Psychoneuroendocrinology. 2020 Dec;122:104883. doi: 10.1016/j.psyneuen.2020.104883. Epub 2020 Sep 24.