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Clinical Trials/NCT04118751
NCT04118751
Unknown
Not Applicable

Impact of Premature Childbirth on Parental Outcomes During Baby's NICU Stay and Beyond: "Preterm Parents" Study on Polish Cohort

University of Gdansk1 site in 1 country100 target enrollmentNovember 5, 2019
ConditionsPremature Birth

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Premature Birth
Sponsor
University of Gdansk
Enrollment
100
Locations
1
Primary Endpoint
Bonding between primary caregiver and infant
Last Updated
5 years ago

Overview

Brief Summary

The main objective of this project is examining whether there is a relationship between preterm delivery and parental' problematic emotional bond in the early postpartum period.

The secondary outcomes are as follows:

  • To evaluate whether there are any differences and similarities between fathers' and mothers' level of parental bonding, stress, anxiety, and depression symptoms in case of premature birth.
  • To evaluate whether there is a relationship between preterm delivery and the persistence of maternal' problematic emotional bond three months after childbirth.
  • To indicate what kind of predictors might affect the parental' problematic bond in the early postpartum period.
Registry
clinicaltrials.gov
Start Date
November 5, 2019
End Date
June 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Łucja Bieleninik

Assistant Professor

University of Gdansk

Eligibility Criteria

Inclusion Criteria

  • Parents of children born below the 37th week of pregnancy (clinical group) or above the 37th week of pregnancy (control group) hospitalised in a neonatal setting during recruitment period
  • Which agreed participating to the study after having complete information about it and sign a consent.

Exclusion Criteria

  • Parents may not participate in the study if one of them suffers from a serious mental illness.

Outcomes

Primary Outcomes

Bonding between primary caregiver and infant

Time Frame: From date of admitted to a NICU until discharge from hospital, assessed up to 7 days after delivery

Mean score of both parents of preterm babies hospitalized in NICU and parent of full-term babies on Postpartum Bonding Questionnaire (PBQ). Total score of the PBQ, a parent-rated screening instrument for disorders of the early parent-infant relationship consisting of 25 statements on a six-point Likert scale (each 0-5; sum score ranging from 0 to 125; high = problematic).

Secondary Outcomes

  • Parental anxiety(From date of admitted to a NICU until discharge from hospital, assessed up to 7 days after delivery)
  • Parental stress(From date of admitted to a NICU until discharge from hospital, assessed up to 7 days after delivery)
  • Bonding between mother and infant(Through study completion, an average of 3 months)
  • Parental depression(From date of admitted to a NICU until discharge from hospital, assessed up to 7 days after delivery)

Study Sites (1)

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