Continuous Delivery Room Skin-to-skin-study for Moderate and Late Preterm Infants

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Cologne

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

preterm birth between gestational age of 32 0/7 and 36 6/7 weeks

vaginal delivery

singleton

informed consent before birth

Disqualifiers

malformations or syndromes of the infant

resuscitation of the infant

maternal psychological or severe physical illness

lack of German language skills

Trial design

Design model

Parallel

Treatments tested in this trial

  • skin-to-skin contact

    Procedure/Surgery

    Immediately after delivery the infant will receive skin-to-skin contact with the mother.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Standard careNo intervention 0 interventions
Group B: skin-to-skin contactExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

gene expression in candidate genes of the stress signalling pathway

DNA will be extracted from peripheral white blood cells and mucosal epithelial cells. The expression of candidate genes of the stress signaling pathways are investigated. The candidate genes are glucocorticoid receptor (NR3C1), corticotropin releasing hormone (CRH), corticotropin-releasing hormone receptor 1 and 2 (CRHR1/2), serotonin transporter (slc6a4), vasopressin and brain-derived neurotrophic factor.

Time frame
36 to 72 hours after birth
2

gene expression in candidate genes of the stress signalling pathway

DNA and RNA will be extracted from mucosal epithelial cells. The expression of candidate genes of the stress signaling pathways are investigated. The candidate genes are glucocorticoid receptor (NR3C1), corticotropin releasing hormone (CRH), corticotropin-releasing hormone receptor 1 and 2 (CRHR1/2), serotonin transporter (slc6a4), vasopressin and brain-derived neurotrophic factor. Furthermore a whole-genome methylation will be analysed.

Time frame
corrected 6 months of age
3

gene expression in candidate genes of the stress signalling pathway

DNA will be extracted from mucosal epithelial cells. The expression of candidate genes of the stress signaling pathways are investigated. The candidate genes are glucocorticoid receptor (NR3C1), corticotropin releasing hormone (CRH), corticotropin-releasing hormone receptor 1 and 2 (CRHR1/2), serotonin transporter (slc6a4), vasopressin and brain-derived neurotrophic factor.

Time frame
corrected 24 months of age

Secondary outcomes

1

mother-child-interaction

Mother-child-interaction is investigated using Mannheim Rating Scales. Therefore a five-minute-videotape of the mother changing the infant's diapers and playing with the infant is used. Mannheim Rating Scales is a good validated standardized observation instrument. Stimulation and response from the mother as well from the infant are being recorded. Different communication channels can be used by mother and child (vocal, facial or motor). All behaviors are analysed at intervals of five seconds (event coding). Then the values are formed from the sum of the coded events. The scale ranges from 0 to 60. If there is no interaction, the scale is 0. If there is an interaction in each interval (every 5 seconds in a 5 minute videotape), the scale is 60. The mother-child interaction is better if the scale is higher.

Time frame
corrected 6 months of age
2

General Movements

The early infant development will be analyzed by general movements assessment by Prechtl. It is a validated diagnostic tool for the functional assessment of the young nervous system.

Time frame
corrected 3 months of age
3

maternal depression

Maternal depression is assessed with the German long form of the Center for Epidemiological Studies Depression Scale (CES-D). It is a self-report questionnaire to measure depressive symptoms and it consists of 20 questions. For each question the response choice are assigned point values (how often a symptom occurred during the last week). The point values are summed to a total measure score. The score ranges from 0 to 60. Zero points represents no symptoms of depression, a score of 15 or higher is interpreted to indicate a risk of depression.

Time frame
at inpatient discharge (assessed from 3 to 60 days of life), corrected 6 and 24 months of age
4

social support

Social support is assessed with the short version of the German questionnaire for social support (Fragebogen zur sozialen Unterstützung, questionnaire on social support) scale (F-SozU K-22). The questionnaire records the subjectively perceived or anticipated support from the social environment. There are 22 items and the test person can indicate the degree of agreement on a five-level Likert scale (from 1 = does not apply to 5 = applies completely). The scale ranges from a minimum of 22 points to a maximum of 110 points. The higher the score, the better the subjectively perceived or anticipated support.

Time frame
at inpatient discharge (assessed from 3 to 60 days of life), corrected 24 months of age

Other outcomes

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