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

Study Overview
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Brief Summary
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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.

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

Conditions
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Premature Birth

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| parents of preterm babies (born before 37 weeks of pregnancy<br> | |
| parents of full-term babies (over 37 weeks of pregnancy)<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parental outcomes, Bonding, NICU