StressNCT00306605
Emotional Experiences in Fathers of NICU Infants
An observational study of Stress and Depressive Symptomatology, run by Christiana Care Health Services at 2 sites in United States.
Trial summary
This study is designed to evaluate the emotional experiences of fathers who have preterm infants who are hospitalized in a (neonatal intensive care unit)NICU setting. In addition, we will compare the emotional responses experienced by father of surgical NICU babies and fathers of medical NICU babies. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Stress, Depressive Symptomatology
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2006to Nov 2008
- 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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Fathers of preterm infants who are hospitalized in a newborn intensive care unit.
Who may be able to join
- consenting fathers who are English speaking
- fathers with preterm infants < 30 weeks gestation and who are likely to survive
- Infants who lack congenital or genetic abnormalities likely to be associated with significant neurodevelopmental handicaps.
Who cannot join
- There are no specific exclusion criteria.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Christiana Hospital (Christiana Care Health Systems)
Newark, Delaware, 19718
A.I. duPont Hospital for Children
Wilmington, Delaware, 19899
About this study
Official title: Emotional Experiences in Fathers of NICU Babies: A Comparison of Fathers in Medical and Surgical NICUs.
This study is designed to evaluate the emotional experiences of fathers who have preterm infants who are hospitalized in a (neonatal intensive care unit)NICU setting. In addition, we will compare the emotional responses experienced by father of surgical NICU babies and fathers of medical NICU babies.
Our primary hypothesis is that paternal stress levels will be lower for those fathers of infants who are hospitalized in a medical NICU compared with fathers of infants who are hospitalized in a surgical NICU.
Secondary hypotheses include: 1) Stress levels for fathers of hospitalized infants will decrease over time; 2) Depressive symptomatology modulates perceived stress in fathers of NICU infants.
Read the detailed description
It is well known that birth and hospitalization of a preterm infant is stressful for parents. Numerous studies have evaluated emotional factors such as maternal stress, parental role alteration, and maternal depression. Researchers have also investigated both maternal and paternal emotional responses in relation to their infant being hospitalized in the NICU. Studies examining paternal response alone have received less research attention. To date, no studies have compared the emotional response of fathers of medical NICU babies and fathers of surgical NICU babies.
The purpose of this study is to evaluate and compare perceived paternal stress and depressive symptomatology in fathers of preterm medical and surgical infants. Fathers who agree to participate will be given a questionnaire that is comprised of two self-report tools. Together these tools should take approximately 15-20 minutes to complete. Fathers who participate will be asked to complete these tools at three different times throughout their infants' stay in the NICU.
- Conditions
- Stress, Depressive Symptomatology
- Being tested
- Questionnaire
- Keywords
- Emotional experiences, fathers, stress, depressive symptomatology, NICU, preterm birth
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Participants will be asked to complete a questionnaire 3 times throughout the first 5 weeks after their infant's birth / hospitalization
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived paternal stress levels will be lower for those fathers of infants who are hospitalized in a medical NICU compared with fathers of infants who are hospitalized in a surgical NICU.
Measured: First 5 weeks of infant's life and / or hospitalization
Secondary outcomes (2)
Stress levels for fathers of hospitalized infants will decrease over time.
Measured: Within the first 5 weeks of their infant's birth / hospitalization
Depressive symptomatology modulates perceived stress in fathers of infants in NICUs.
Measured: First 5 weeks after their infant's birth / hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionSep 2008
- Study completionNov 2008
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 StressStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Collaborators
- Alfred I. duPont Hospital for Children
- Responsible party
- Principal investigator, Amy Mackley, Christiana Care Health Services
- Investigators
- Amy B. Mackley, MSN, RNC, Principal investigator, Christiana Care Health SystemsMichael L. Spear, MD, Principal investigator, Christiana Care Health Systems; A.I. duPont Hospital for ChildrenRobert G. Locke, DO, Principal investigator, Christiana Care Health Systems; A.I. duPont Hospital for ChildrenRachel Joseph, MSN, CCRN, Principal investigator, Alfred I. duPont Hospital for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00306605
- Sponsor's protocol ID
- 26047
- Status last verified
- Jun 2017
- First submitted
- 22 Mar 2006
- Last updated
- 21 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Miles MS, Brunssen SH. Psychometric properties of the parental stressor scale: infant hospitalization. Adv Neonatal Care. 2003 Aug;3(4):189-96. doi: 10.1016/s1536-0903(03)00138-3.
PubMed 14502526
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional Experiences in Fathers of NICU Babies: A Comparison of Fathers in Medical and Surgical NICUs.
- ClinicalTrials.gov ID
- NCT00306605
- Acronym / sponsor ID
- 26047
- Conditions
- Stress, Depressive Symptomatology
- Keywords
- Emotional experiences, fathers, stress, depressive symptomatology, NICU, preterm birth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Collaborators
- Alfred I. duPont Hospital for Children
- Study start
- Mar 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 24 Mar 2006 (estimated)
- 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.
This study is designed to evaluate the emotional experiences of fathers who have preterm infants who are hospitalized in a (neonatal intensive care unit)NICU setting. In addition, we will compare the emotional responses experienced by father of surgical NICU babies and fathers of medical NICU babies.
Our primary hypothesis is that paternal stress levels will be lower for those fathers of infants who are hospitalized in a medical NICU compared with fathers of infants who are hospitalized in a surgical NICU.
Secondary hypotheses include: 1) Stress levels for fathers of hospitalized infants will decrease over time; 2) Depressive symptomatology modulates perceived stress in fathers of NICU infants.
Detailed description
It is well known that birth and hospitalization of a preterm infant is stressful for parents. Numerous studies have evaluated emotional factors such as maternal stress, parental role alteration, and maternal depression. Researchers have also investigated both maternal and paternal emotional responses in relation to their infant being hospitalized in the NICU. Studies examining paternal response alone have received less research attention. To date, no studies have compared the emotional response of fathers of medical NICU babies and fathers of surgical NICU babies.
The purpose of this study is to evaluate and compare perceived paternal stress and depressive symptomatology in fathers of preterm medical and surgical infants. Fathers who agree to participate will be given a questionnaire that is comprised of two self-report tools. Together these tools should take approximately 15-20 minutes to complete. Fathers who participate will be asked to complete these tools at three different times throughout their infants' stay in the NICU.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Fathers of preterm infants who are hospitalized in a newborn intensive care unit.
Key inclusion criteria (3 listed)
- consenting fathers who are English speaking
- fathers with preterm infants < 30 weeks gestation and who are likely to survive
- Infants who lack congenital or genetic abnormalities likely to be associated with significant neurodevelopmental handicaps.
Key exclusion criteria (1 listed)
- There are no specific exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireParticipants will be asked to complete a questionnaire 3 times throughout the first 5 weeks after their infant's birth / hospitalization | Behavioural | – |
Primary outcome
Perceived paternal stress levels will be lower for those fathers of infants who are hospitalized in a medical NICU compared with fathers of infants who are hospitalized in a surgical NICU.
Time frame: First 5 weeks of infant's life and / or hospitalization
2 secondary outcomes
Stress levels for fathers of hospitalized infants will decrease over time.
Time frame: Within the first 5 weeks of their infant's birth / hospitalization
Depressive symptomatology modulates perceived stress in fathers of infants in NICUs.
Time frame: First 5 weeks after their infant's birth / hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2017.
- Background: PubMed 14502526Miles MS, Brunssen SH. Psychometric properties of the parental stressor scale: infant hospitalization. Adv Neonatal Care. 2003 Aug;3(4):189-96. doi: 10.1016/s1536-0903(03)00138-3.
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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.
Amy B. Mackley, MSN, RNC principal investigator
Christiana Care Health Systems
Michael L. Spear, MD principal investigator
Christiana Care Health Systems; A.I. duPont Hospital for Children
Robert G. Locke, DO principal investigator
Christiana Care Health Systems; A.I. duPont Hospital for Children
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress and Depressive Symptomatology, run by Christiana Care Health Services at 2 sites in United States.
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 3 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: finished, as of the sponsor's last update on 21 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived paternal stress levels will be lower for those fathers of infants who are hospitalized in a medical NICU compared with fathers of infants who are hospitalized in a surgical NICU. (time frame: First 5 weeks of infant's life and / or hospitalization). 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 NCT00306605, 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 21 Jun 2017.