Impact of Premature Childbirth on Parental Outcomes During Baby's NICU Stay and Beyond

June 4, 2020 updated by: Łucja Bieleninik, University of Gdansk

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
      • Gdańsk, Poland, 80-210
        • Recruiting
        • Medical University of Gdansk
        • Principal Investigator:
          • Łucja Bieleninik, PhD
        • Sub-Investigator:
          • Mariola Bidzan, Prof
        • Sub-Investigator:
          • Joanna Preis-Orlikowska, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The investigators will approach parents of preterm babies (born before 37 weeks of pregnancy) and parents of babies born on time (over 37 weeks of pregnancy). Patients will be recruited for the study after delivery and will be enrolled after giving their written consent to participate in the study.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
parents of preterm babies (born before 37 weeks of pregnancy
parents of full-term babies (over 37 weeks of pregnancy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From date of admitted to a NICU until discharge from hospital, assessed up to 7 days after delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental depression
Time Frame: From date of admitted to a NICU until discharge from hospital, assessed up to 7 days after delivery
Mean score of parents of preterm infants hospitalized in NICU on Edinburgh Postnatal Depression Scale (EPDS). The EPDS is a 10-item validated self-report instrument assessing mothers' postpartum depressive symptoms, excluding somatic symptoms of depression that are common in new mothers (such as loss of energy, feeling tired, changes in appetite and sexual drive). Sum scores can range from 0 to 30, with high scores indicating more depressive symptoms.
From date of admitted to a NICU until discharge from hospital, assessed up to 7 days after delivery
Parental anxiety
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 infants hospitalized in NICU on Generalized Anxiety Disorder Assessment (GAD-7). The GAD-7 is a self-report 7-item questionnaire serving as a screening tool and severity measure for generalized anxiety disorder. Sum scores can range from 0 to 21, with higher scores indicating higher anxiety.
From date of admitted to a NICU until discharge from hospital, assessed up to 7 days after delivery
Parental stress
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 infants hospitalized in NICU on Parental Stress Scale (PSS). PSS is a self-report 18-item questionnaire that assesses stress associated with parenting. Sum scores can range from 18 to 90, with higher scores indicating higher stress.
From date of admitted to a NICU until discharge from hospital, assessed up to 7 days after delivery
Bonding between mother and infant
Time Frame: Through study completion, an average of 3 months
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).
Through study completion, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Gdansk

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2019

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

October 4, 2019

First Submitted That Met QC Criteria

October 7, 2019

First Posted (Actual)

October 8, 2019

Study Record Updates

Last Update Posted (Actual)

June 5, 2020

Last Update Submitted That Met QC Criteria

June 4, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9/2019

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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