Improving Asthma Care for Very Low Birth Weight Infants

This study has been completed.
Sponsor:
Collaborator:
Halcyon Hill Foundation
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00156507
First received: September 8, 2005
Last updated: May 11, 2011
Last verified: May 2011
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Improving Asthma Care for Very Low Birth Weight Infants

Resource links provided by NLM:


Further study details as provided by University of Rochester:

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 [ Time Frame: 7-9 months post discharge ] [ Designated as safety issue: No ]

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. [ Time Frame: 1-3 years post baseline ] [ Designated as safety issue: No ]

Enrollment: 192
Study Start Date: January 2003
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
Asthma education is provided to parents of children in the experimental group prior to nicu discharge.

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156507

Locations
United States, New York
Strong Memorial Hospital - Neonatal Intensive Care Unit
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Halcyon Hill Foundation
Investigators
Principal Investigator: Jill S Halterman, MD, MPH University of Rochester
  More Information

No publications provided

Responsible Party: Jill S. Halterman, MD, MPH, Halcyon Hill Foundation
ClinicalTrials.gov Identifier: NCT00156507     History of Changes
Other Study ID Numbers: 09653
Study First Received: September 8, 2005
Last Updated: May 11, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Asthma
Birth Weight
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014