Emotional Experiences in Fathers of NICU Infants
1 other identifier
observational
35
1 country
2
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2006
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 22, 2006
CompletedFirst Posted
Study publicly available on registry
March 24, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedJune 21, 2017
June 1, 2017
2.5 years
March 22, 2006
June 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
First 5 weeks of infant's life and / or hospitalization
Secondary Outcomes (2)
Stress levels for fathers of hospitalized infants will decrease over time.
Within the first 5 weeks of their infant's birth / hospitalization
Depressive symptomatology modulates perceived stress in fathers of infants in NICUs.
First 5 weeks after their infant's birth / hospitalization
Interventions
Participants will be asked to complete a questionnaire 3 times throughout the first 5 weeks after their infant's birth / hospitalization
Eligibility Criteria
Fathers of preterm infants who are hospitalized in a newborn intensive care unit.
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Christiana Hospital (Christiana Care Health Systems)
Newark, Delaware, 19718, United States
A.I. duPont Hospital for Children
Wilmington, Delaware, 19899, United States
Related Publications (1)
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.
PMID: 14502526BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amy B. Mackley, MSN, RNC
Christiana Care Health Systems
- PRINCIPAL INVESTIGATOR
Michael L. Spear, MD
Christiana Care Health Systems; A.I. duPont Hospital for Children
- PRINCIPAL INVESTIGATOR
Robert G. Locke, DO
Christiana Care Health Systems; A.I. duPont Hospital for Children
- PRINCIPAL INVESTIGATOR
Rachel Joseph, MSN, CCRN
Alfred I. duPont Hospital for Children
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Amy Mackley
Study Record Dates
First Submitted
March 22, 2006
First Posted
March 24, 2006
Study Start
March 1, 2006
Primary Completion
September 1, 2008
Study Completion
November 1, 2008
Last Updated
June 21, 2017
Record last verified: 2017-06