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

Premature Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04118751
• Other study ID #: 9/2019
• Status: Recruiting
• Start date: November 5, 2019
• Est. completion date: June 2021

Study information

• Verified date: June 2020
• Source: University of Gdansk
• Contact: Lucja Bieleninik, PhD
• Phone: 0048 504 091 477
• Email: lucja.bieleninik[@]ug.edu.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2021
• Est. primary completion date: December 2020
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth

Locations

Country	Name	City	State
Poland	Medical University of Gdansk	Gdansk

Sponsors (1)

Lead Sponsor	Collaborator
University of Gdansk

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Parental depression	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
Secondary	Parental anxiety	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
Secondary	Parental stress	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
Secondary	Bonding between mother 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).	Through study completion, an average of 3 months