We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Emotional Experiences in Fathers of NICU Infants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00306605
First Posted: March 24, 2006
Last Update Posted: June 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Alfred I. duPont Hospital for Children
Information provided by (Responsible Party):
Amy Mackley, Christiana Care Health Services
  Purpose

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.


Condition Intervention
Stress Depressive Symptomatology Behavioral: Questionnaire

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: Emotional Experiences in Fathers of NICU Babies: A Comparison of Fathers in Medical and Surgical NICUs.

Further study details as provided by Amy Mackley, Christiana Care Health Services:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 35
Study Start Date: March 2006
Study Completion Date: November 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Questionnaire
    Participants will be asked to complete a questionnaire 3 times throughout the first 5 weeks after their infant's birth / hospitalization
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   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.
Criteria

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:

  • There are no specific exclusion criteria.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00306605


Locations
United States, Delaware
Christiana Hospital (Christiana Care Health Systems)
Newark, Delaware, United States, 19718
A.I. duPont Hospital for Children
Wilmington, Delaware, United States, 19899
Sponsors and Collaborators
Christiana Care Health Services
Alfred I. duPont Hospital for Children
Investigators
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
  More Information

Publications:
Responsible Party: Amy Mackley, Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT00306605     History of Changes
Other Study ID Numbers: 26047
First Submitted: March 22, 2006
First Posted: March 24, 2006
Last Update Posted: June 21, 2017
Last Verified: June 2017

Keywords provided by Amy Mackley, Christiana Care Health Services:
Emotional experiences
fathers
stress
depressive symptomatology
NICU
preterm birth