Clinical trial NCT00306605: Emotional Experiences in Fathers of NICU Infants
Official title: Emotional Experiences in Fathers of NICU Babies: A Comparison of Fathers in Medical and Surgical NICUs.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress
Depressive Symptomatology
Keywords: Emotional experiences
fathers
stress
depressive symptomatology
NICU
preterm birth
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
Collaborators: name: Alfred I. duPont Hospital for Children
First posted: 2006-03-24
Enrollment: 35
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fathers of preterm infants who are hospitalized in a newborn intensive care unit.

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.

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 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.

Primary outcomes:
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.
timeFrame: First 5 weeks of infant's life and / or hospitalization
Secondary outcomes:
measure: Stress levels for fathers of hospitalized infants will decrease over time.
timeFrame: Within the first 5 weeks of their infant's birth / hospitalization
measure: Depressive symptomatology modulates perceived stress in fathers of infants in NICUs.
timeFrame: First 5 weeks after their infant's birth / hospitalization
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Hospital (Christiana Care Health Systems)
state: Delaware
city: Wilmington
country: United States
facility: A.I. duPont Hospital for Children
state: Delaware
Study officials:
affiliation: Christiana Care Health Systems
name: Amy B. Mackley, MSN, RNC
role: PRINCIPAL_INVESTIGATOR
affiliation: Christiana Care Health Systems; A.I. duPont Hospital for Children
name: Michael L. Spear, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Christiana Care Health Systems; A.I. duPont Hospital for Children
name: Robert G. Locke, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Alfred I. duPont Hospital for Children
name: Rachel Joseph, MSN, CCRN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.