Improving Asthma Care for Very Low Birth Weight Infants

Asthma Clinical Trial

Official title:

Improving Asthma Care for Very Low Birth Weight Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00156507
• Other study ID #: 09653
• Status: Completed
• Phase: N/A
• First received: September 8, 2005
• Last updated: May 11, 2011
• Start date: January 2003
• Est. completion date: June 2006

Study information

• Verified date: May 2011
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Year

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Asthma
• Birth Weight

Intervention

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.

Locations

Country	Name	City	State
United States	Strong Memorial Hospital - Neonatal Intensive Care Unit	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	Halcyon Hill Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No