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NCT02623400

The Effect of Perinatal Stress on the Development of Preterm Infants

Sponsor: Universitaire Ziekenhuizen KU Leuven

View on ClinicalTrials.gov

Summary

In this project, the investigators will study a cohort of preterm infants, together with their parents, during NICU hospitalization and follow their developmental trajectory until the age of two. An important first scientific goal of the project is to identify objective stress markers that can be obtained easily and non-invasively in preterm infants during NICU hospitalization. This will include the development of novel techniques to measure stress related heart rate variability (HRV) and EEG maturation, as well as sleep stage markers for preterm infants. Secondly, the investigators will study the emotional and bonding processes in parents of preterm infants. Parental distress in terms of depressive symptoms, anxiety, perceived stress and parent-infant bonding will be measured at multiple measuring points. This will enable the validation of psychometric instruments in the specific population of parents of preterm infants. Also, the investigators can investigate the effect and predictive value of the course of parental depression, anxiety and stress scores on child's developmental outcome and on parent-infant bonding and attachment. Thirdly, studies on epigenetic changes due to prenatal stress are still scarce in humans. In this study, the investigators will include a cohort of mothers experiencing profound prenatal stress due to preterm labor, which will complement the earlier work that has been carried out in a low-risk population. The investigators expect more profound changes in methylation state of the NR3C1 and other promotor regions in their cohort of mothers exposed to important prenatal stress. Secondly, the methylation of oxytocin receptor regions will be studied in relation to attachment and bonding. An important overall goal of the project is to develop a Perinatal Stress Calculator that studies the value of the different neonatal, endocrinological, psychological and physiological stress-related parameters to predict differences in psychomotor, cognitive, behavioral, and emotional development. This longitudinal study design will enable the investigators to use the perinatal stress calculator to study the relation between the perinatal stress parameters and later developmental disabilities such as motor impairment, cognitive deficits, language delay but also social and behavioral problems such as attentional deficits and emotional self-regulation dysfunction.

Key Details

Gender

All

Age Range

Any - 34 Weeks

Study Type

OBSERVATIONAL

Enrollment

174

Start Date

2016-07

Completion Date

2025-12

Last Updated

2024-07-03

Healthy Volunteers

No

Locations (1)

UZLEUVEN

Leuven, Vlaams-Brabant, Belgium