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Improving Asthma Care for Very Low Birth Weight Infants

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Asthma education for parents of very low birth weight infants
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asthma

Eligibility Criteria

30 Days - 1 Year (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Premature babies weighing less than 1500 grams at birth receiving care at Strong Memorial Hospital Neonatal Intensive Care Unit Exclusion Criteria: Non-English speaking parents

Sites / Locations

  • Strong Memorial Hospital - Neonatal Intensive Care Unit

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 8, 2005
Last Updated
May 11, 2011
Sponsor
University of Rochester
Collaborators
Halcyon Hill Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00156507
Brief Title
Improving Asthma Care for Very Low Birth Weight Infants
Official Title
Improving Asthma Care for Very Low Birth Weight Infants
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Rochester
Collaborators
Halcyon Hill Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
192 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Parents of children in the experimental group receive asthma education prior to NICU discharge.
Intervention Type
Behavioral
Intervention Name(s)
Asthma education for parents of very low birth weight infants
Intervention Description
Asthma education is provided to parents of children in the experimental group prior to nicu discharge.
Primary Outcome Measure Information:
Title
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
Time Frame
7-9 months post discharge
Secondary Outcome Measure Information:
Title
To evaluate the feasibility of implementing the intervention in terms of cost and personnel time and to obtain parental feedback about the intervention.
Time Frame
1-3 years post baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Days
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Premature babies weighing less than 1500 grams at birth receiving care at Strong Memorial Hospital Neonatal Intensive Care Unit Exclusion Criteria: Non-English speaking parents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill S Halterman, MD, MPH
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Strong Memorial Hospital - Neonatal Intensive Care Unit
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

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Improving Asthma Care for Very Low Birth Weight Infants

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