Impact of Premature Childbirth on Parental Outcomes During Baby's NICU Stay and Beyond
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2019
CompletedFirst Posted
Study publicly available on registry
October 8, 2019
CompletedStudy Start
First participant enrolled
November 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedJune 5, 2020
June 1, 2020
1.1 years
October 4, 2019
June 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bonding between primary caregiver and infant
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 Outcomes (4)
Parental depression
From date of admitted to a NICU until discharge from hospital, assessed up to 7 days after delivery
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
Study Arms (2)
parents of preterm babies (born before 37 weeks of pregnancy
parents of full-term babies (over 37 weeks of pregnancy)
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Parents may not participate in the study if one of them suffers from a serious mental illness.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Gdańsk
Gdansk, 80-210, Poland
Related Publications (1)
Bieleninik L, Lutkiewicz K, Jurek P, Bidzan M. Paternal Postpartum Bonding and Its Predictors in the Early Postpartum Period: Cross-Sectional Study in a Polish Cohort. Front Psychol. 2021 Apr 9;12:628650. doi: 10.3389/fpsyg.2021.628650. eCollection 2021.
PMID: 33897536DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 4, 2019
First Posted
October 8, 2019
Study Start
November 5, 2019
Primary Completion
December 1, 2020
Study Completion
June 1, 2021
Last Updated
June 5, 2020
Record last verified: 2020-06