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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01006928
Other study ID # HY0015-09-IL
Secondary ID
Status Completed
Phase N/A
First received November 1, 2009
Last updated June 5, 2011
Start date December 2009
Est. completion date June 2010

Study information

Verified date June 2011
Source Hillel Yaffe Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial Summary

Preterm birth is a traumatic event for parents. They cope with threatening and unfamiliar environment of hospital, losing the parental role, and frustration. The NICU team is the main support source for these parents. Support and providing information are most important for parents, as they can have some control, involvement and self confidence during the hospitalization, and also feel healthier. The hypothesis of this study is that better support to parents lead to better subjective health feeling by them.

The study will be held among mothers to infants in NICU who are at least 7 days old. The study will use a questionaire to assess the subjective health feeling and the estimation of the support from the team. Sample size is about 150 mothers.


Description:

Preterm birth is a traumatic event for parents. They cope with threatening and unfamiliar environment of hospital, losing the parental role, and frustration. The NICU team is the main support source for these parents. Support and providing information are most important for parents, as they can have some control, involvement and self confidence during the hospitalization, and also feel healthier. The hypothesis of this study is that better support to parents lead to better subjective health feeling by them.

The study will be held among mothers to infants in NICU who are at least 7 days old. The study will use a questionaire to assess the subjective health feeling and the estimation of the support from the team. Sample size is about 150 mothers.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date June 2010
Est. primary completion date June 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 60 Years
Eligibility Inclusion Criteria:

- Mothers to preterm infants in NICU

Exclusion Criteria:

- Mothers to Infants in NICU who are not preterm

- Mothers to Infants in NICU who died during hospitalization

- Mothers to Infants in NICU who were transferred to another hospital during hospitalization

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms

  • Conditions Influencing Health Status

Intervention

Other:
Questionaire
Questionaire to mothers

Locations

Country Name City State
Israel Hillel Yaffe medical center Hadera

Sponsors (1)

Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (2)

Arockiasamy V, Holsti L, Albersheim S. Fathers' experiences in the neonatal intensive care unit: a search for control. Pediatrics. 2008 Feb;121(2):e215-22. doi: 10.1542/peds.2007-1005. Epub 2008 Jan 8. — View Citation

Bloom KC. The development of attachment behaviors in pregnant adolescents. Nurs Res. 1995 Sep-Oct;44(5):284-9. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Good subjective health feeling of mother. 6 months No
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