NCT00699127

Brief Summary

Being a parent to a premature infant in NICU is an anxious state. Parents ask a lot of questions, and look for information all the time. Organizing the information given to parents could reduce their anxiety. The parents will be divided into two groups: one group will get organized information, by a lecture at the first week of their infant's life, and the other group will not. Of course, questions will be answered all the time. The parents will answer a questionnaire on the first week of the infant's life, and on the last week, just before releasing the infant home.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 17, 2008

Completed
14 days until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

July 4, 2008

Status Verified

July 1, 2008

Enrollment Period

Same day

First QC Date

June 14, 2008

Last Update Submit

July 3, 2008

Conditions

Anxiety

Keywords

anxietyparentsNICUprematurityAnxiety of parents to NICU infants

Outcome Measures

Primary Outcomes (1)

  • Difference between questionnaires at the first week and the last week to hospitalization.

    1 year

Study Arms (2)

1

EXPERIMENTAL

The group that will have lecture of information regarding infants in NICU.

Behavioral: Lecture

2

NO INTERVENTION

The group that will not have lecture of information regarding NICU hospitalization

Interventions

LectureBEHAVIORAL

Lecture of information regarding prematurity, NICU hospitalization, etc.

1

Eligibility Criteria

AgeUp to 4 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Parents to premature infants, after releasing the mother

You may not qualify if:

  • Term infants
  • Hospitalized mother

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe medical center

Hadera, Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Anxiety DisordersPremature Birth

Condition Hierarchy (Ancestors)

Mental DisordersObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Erez Nadir, MD

    Hillel Yaffe medical center, Hadera, Israel

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

June 14, 2008

First Posted

June 17, 2008

Study Start

July 1, 2008

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

July 4, 2008

Record last verified: 2008-07

Locations

IL(1)