NCT01006928

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

November 1, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 3, 2009

Completed
28 days until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

June 8, 2011

Status Verified

June 1, 2011

Enrollment Period

6 months

First QC Date

November 1, 2009

Last Update Submit

June 5, 2011

Conditions

Conditions Influencing Health Status

Keywords

Subjective health feelingNICUteam support

Outcome Measures

Primary Outcomes (1)

  • Good subjective health feeling of mother.

    6 months

Study Arms (1)

Mothers

Mother of infants in NICU

Other: Questionaire

Interventions

QuestionaireOTHER

Questionaire to mothers

Mothers

Eligibility Criteria

AgeUp to 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Mothers of infants in NICU

You may qualify if:

  • Mothers to preterm infants in NICU

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe medical center

Hadera, Israel, Israel

Location

Related 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.

    PMID: 18182470BACKGROUND

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

    PMID: 7567484BACKGROUND

Study Officials

  • Erez Nadir, MD

    Hillel Yaffe medical centet, Hadera, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 1, 2009

First Posted

November 3, 2009

Study Start

December 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

June 8, 2011

Record last verified: 2011-06

Locations

IL(1)