The Effect of Perinatal Stress on the Development of Preterm Infants

NCT02623400 | Active Not Recruiting

• 1 other identifier: S58807
• Study Type: observational
• Target: 174
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Premature Birth of Newborn

Keywords

preterm birth; perinatal stress; growth and development

Outcome Measures

Primary Outcomes (1)

• Attachment behavior (will be assessed using questionnaires and both free and structured observations of the child-parent interaction)

  24 months

Secondary Outcomes (12)

• Psychomotor development (will be assessed using Infant Scales of Development)

  24 months

• Cognitive development (will be assessed using Infant Scales of Development)

  24 months

• Cognitive development (executive functioning will be assessed by the Snack Delay Task)

  24 months

• Language development (will be assessed using Infant Scales of Development)

  24 months

• Language development (will be assessed using the NCDI-2A)

  24 months

Study Arms (1)

Preterm infants and their parents

Preterm infants born before 34 weeks gestational age and/or with a birth weight lower than 1500g and their parents.

Eligibility Criteria

• Age: Up to 34 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The investigators will approach parents of preterm infants born before 34 weeks gestational age and/or with a birth weight lower than 1500g. Ideally, pregnant women admitted to the maternal intensive care (MIC) for preterm labor will be informed about the study together with their partner, and asked for consent. But in a number of preterm infants prenatal inclusion will not be possible (e.g. birth in another hospital, preterm premature rupture of the membranes,…) . Parents of infants in this subgroup, who are admitted to the Neonatal Intensive Care Unit (NICU) at the University Hospitals Leuven, will be informed and asked for consent within 3 days after birth.

You may qualify if:

• Preterm infants born before 34 weeks gestational age and/or with a birth weight lower than 1500g and their parents

You may not qualify if:

• Age \< 18yr.
• Unable to speak and understand Dutch, French or English
• Unstable medical (somatic and/or psychiatric) disease in the parent(s)
• The presence of a major congenital malformation in the preterm infant

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• KU Leuven: collaborator

Study Sites (1)

UZLEUVEN

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Related Publications (58)

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Biospecimen

Retention: SAMPLES WITH DNA

saliva samples of both parents and the child, blood sample of mother and child, cord blood sample,

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 Officials

• Gunnar Naulaers, MD, PhD

  UZ / KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: December 7, 2015
• Study Start: July 1, 2016
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)