Premature BirthNCT04118751
Impact of Premature Childbirth on Parental Outcomes During Baby's NICU Stay and Beyond
An observational study of Premature Birth, run by University of Gdansk at 1 site in Poland.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Premature Birth
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 5 Nov 2019to Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- Parents may not participate in the study if one of them suffers from a serious mental illness.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Medical University of Gdańsk
Gdansk, 80-210
Łucja Bieleninik, PhD
Mariola Bidzan, Prof
About this study
Official title: Impact of Premature Childbirth on Parental Outcomes During Baby's NICU Stay and Beyond: "Preterm Parents" Study on Polish Cohort
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.
- Conditions
- Premature Birth
- Keywords
- Parental outcomes, Bonding, NICU
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| parents of preterm babies (born before 37 weeks of pregnancy | Not described | |
| parents of full-term babies (over 37 weeks of pregnancy) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From date of admitted to a NICU until discharge from hospital, assessed up to 7 days after delivery
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start5 Nov 2019
- Primary completionDec 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Łucja Bieleninik, University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118751
- Sponsor's protocol ID
- 9/2019
- Status last verified
- Jun 2020
- First submitted
- 4 Oct 2019
- Last updated
- 5 Jun 2020
- Results posted
- No
Publications
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.
PubMed 33897536
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Premature Childbirth on Parental Outcomes During Baby's NICU Stay and Beyond: "Preterm Parents" Study on Polish Cohort
- ClinicalTrials.gov ID
- NCT04118751
- Acronym / sponsor ID
- 9/2019
- Conditions
- Premature Birth
- Keywords
- Parental outcomes, Bonding, NICU
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of GdanskUniversity, hospital or other
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 8 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| parents of preterm babies (born before 37 weeks of pregnancy | – | – |
| parents of full-term babies (over 37 weeks of pregnancy) | – | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Parents may not participate in the study if one of them suffers from a serious mental illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bonding between primary caregiver and infant
Time frame: From date of admitted to a NICU until discharge from hospital, assessed up to 7 days after delivery
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).
4 secondary outcomes
Parental depression
Time frame: From date of admitted to a NICU until discharge from hospital, assessed up to 7 days after delivery
Parental anxiety
Time frame: From date of admitted to a NICU until discharge from hospital, assessed up to 7 days after delivery
Parental stress
Time frame: From date of admitted to a NICU until discharge from hospital, assessed up to 7 days after delivery
Bonding between mother and infant
Time frame: Through study completion, an average of 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- Derived from this study: PubMed 33897536Bieleninik 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Birth, run by University of Gdansk at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Łucja Bieleninik, PhD (0048 504 091 477, lucja.bieleninik@ug.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bonding between primary caregiver and infant (time frame: From date of admitted to a NICU until discharge from hospital, assessed up to 7 days after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04118751, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2020.