NCT00306605

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2006

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 24, 2006

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

June 21, 2017

Status Verified

June 1, 2017

Enrollment Period

2.5 years

First QC Date

March 22, 2006

Last Update Submit

June 19, 2017

Conditions

Keywords

Emotional experiencesfathersstressdepressive symptomatologyNICUpreterm birth

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

QuestionnaireBEHAVIORAL

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

Eligibility Criteria

Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

A.I. duPont Hospital for Children

Wilmington, Delaware, 19899, United States

Location

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

Premature Birth

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

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

Locations