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Completed

NCT Number: NCT00306605

Emotional Experiences in Fathers of NICU Infants

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.

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Key information

Conditions

Stress Depressive Symptomatology Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Sex eligibility

Male

Study type

Observational

Primary location

Christiana Hospital (Christiana Care Health Systems), Newark, Delaware, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Questionnaire

Behavioral

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

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

Sponsors and collaborators

Lead sponsor

Christiana Care Health Services

Other

Collaborators

  • Alfred I. duPont Hospital for Children

Registry information

Official study title

Emotional Experiences in Fathers of NICU Babies: A Comparison of Fathers in Medical and Surgical NICUs.

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Mar 24, 2006
Registry last updated
Jun 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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