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CompletedNCT00306605Updated Jun 21, 2017

Emotional Experiences in Fathers of NICU Infants

An observational study in Stress and Depressive Symptomatology, sponsored by Christiana Care Health Services. Completed at 2 sites in United States. Open to male participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-21.

Sponsored by Christiana Care Health Services · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
35
Sex
Male
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Study 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.

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.

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Conditions studied

  • Stress
  • Depressive Symptomatology

Keywords

  • Emotional experiences
  • fathers
  • stress
  • depressive symptomatology
  • NICU
  • preterm birth
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In context

Lead sponsor

Christiana Care Health Services is the lead sponsor of 94 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Fathers of preterm infants who are hospitalized in a newborn intensive care unit.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • There are no specific exclusion criteria.
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
35 participants (actual)

Interventions

  • BehavioralQuestionnaire

    Participants will be asked to complete a questionnaire 3 times throughout the first 5 weeks after their infant's birth / hospitalization

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What researchers measure

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.

    Time frame: First 5 weeks of infant's life and / or hospitalization

Secondary outcomes

  1. Stress levels for fathers of hospitalized infants will decrease over time.

    Time frame: Within the first 5 weeks of their infant's birth / hospitalization

  2. Depressive symptomatology modulates perceived stress in fathers of infants in NICUs.

    Time frame: First 5 weeks after their infant's birth / hospitalization

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Study locations

2 sites
  • Christiana Hospital (Christiana Care Health Systems)
    Newark, Delaware 19718, United States
  • A.I. duPont Hospital for Children
    Wilmington, Delaware 19899, United States
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References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00306605
Lead sponsor
Christiana Care Health Services
Collaborators
Alfred I. duPont Hospital for Children
Responsible party
Amy Mackley (Amy Mackley, Christiana Care Health Services) — Principal investigator
First posted
Mar 24, 2006
Start date
Mar 2006
Primary completion
Sep 2008
Completion
Nov 2008
Last update
Jun 21, 2017

Study contacts

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
Rachel Joseph, MSN, CCRN
principal investigator · Alfred I. duPont Hospital for Children

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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