Clinical trial NCT04118751: Impact of Premature Childbirth on Parental Outcomes During Baby's NICU Stay and Beyond
Official title: Impact of Premature Childbirth on Parental Outcomes During Baby's NICU Stay and Beyond: "Preterm Parents" Study on Polish Cohort
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Premature Birth
Keywords: Parental outcomes
Bonding
NICU
Lead sponsor: University of Gdansk
Sponsor class: OTHER
First posted: 2019-10-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Bonding between primary caregiver and infant
timeFrame: From date of admitted to a NICU until discharge from hospital, assessed up to 7 days after delivery
Secondary outcomes:
measure: Parental depression
timeFrame: From date of admitted to a NICU until discharge from hospital, assessed up to 7 days after delivery
measure: Parental anxiety
timeFrame: From date of admitted to a NICU until discharge from hospital, assessed up to 7 days after delivery
measure: Parental stress
timeFrame: From date of admitted to a NICU until discharge from hospital, assessed up to 7 days after delivery
measure: Bonding between mother and infant
timeFrame: Through study completion, an average of 3 months
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Medical University of Gdańsk
Study officials:
References:
citation: 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.