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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04118751
Enrollment
100
Registered
2019-10-08
Start date
2019-11-05
Completion date
2021-06-30
Last updated
2020-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Birth

Keywords

Parental outcomes, Bonding, NICU

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.

Interventions

None listed

Sponsors

University of Gdansk
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Bonding between primary caregiver and infantFrom date of admitted to a NICU until discharge from hospital, assessed up to 7 days after deliveryMean 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

MeasureTime frameDescription
Parental depressionFrom date of admitted to a NICU until discharge from hospital, assessed up to 7 days after deliveryMean 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.
Parental anxietyFrom date of admitted to a NICU until discharge from hospital, assessed up to 7 days after deliveryMean 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.
Parental stressFrom date of admitted to a NICU until discharge from hospital, assessed up to 7 days after deliveryMean 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.
Bonding between mother and infantThrough study completion, an average of 3 monthsMean 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).

Countries

Poland

Contacts

Primary ContactŁucja Bieleninik, PhD
lucja.bieleninik@ug.edu.pl0048 504 091 477

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026