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

NCT ID: NCT04118751

Last Updated: 2020-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-05

Study Completion Date

2021-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Premature Birth

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

parents of preterm babies (born before 37 weeks of pregnancy

No interventions assigned to this group

parents of full-term babies (over 37 weeks of pregnancy)

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Gdansk

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Łucja Bieleninik

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical University of Gdańsk

Gdansk, , Poland

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Poland

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Łucja Bieleninik, PhD

Role: CONTACT

0048 504 091 477

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 33897536 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

9/2019

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Effectiveness of Audiovisual Intervention
NCT06525142 NOT_YET_RECRUITING NA
Delivery Room Skin-to-skin Study
NCT01959737 COMPLETED NA