NCT00156507

Brief Summary

Children born less than 1500 grams are being enrolled into a study to test the effectiveness of a parental educational intervention in reducing the risk of future breathing problems. The intervention teaches parents of these children how to reduce the risk of / and recognize breathing problems.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
192

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Jan 2003

Typical duration for not_applicable asthma

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

May 12, 2011

Status Verified

May 1, 2011

Enrollment Period

3.4 years

First QC Date

September 8, 2005

Last Update Submit

May 11, 2011

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • To evaluate whether education about asthma improves parent knowledge about the disease and its management and to evaluate whether education about asthma influences healthy behaviors to reduce breathing problems

    7-9 months post discharge

Secondary Outcomes (1)

  • To evaluate the feasibility of implementing the intervention in terms of cost and personnel time and to obtain parental feedback about the intervention.

    1-3 years post baseline

Study Arms (1)

1

EXPERIMENTAL

Parents of children in the experimental group receive asthma education prior to NICU discharge.

Behavioral: Asthma education for parents of very low birth weight infants

Interventions

Asthma education for parents of very low birth weight infantsBEHAVIORAL

Asthma education is provided to parents of children in the experimental group prior to nicu discharge.

1

Eligibility Criteria

Age30 Days - 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Premature babies weighing less than 1500 grams at birth receiving care at Strong Memorial Hospital Neonatal Intensive Care Unit

You may not qualify if:

  • Non-English speaking parents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Strong Memorial Hospital - Neonatal Intensive Care Unit

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Jill S Halterman, MD, MPH

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

January 1, 2003

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

May 12, 2011

Record last verified: 2011-05

Locations

US(1)