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Post-hospitalization Nursing Effectiveness (PHONE) Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00314431
First Posted: April 13, 2006
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )
  Purpose
Based on success with telephone follow up for other groups of medically fragile infants, we designed an innovative model of post-hospital comprehensive and coordinated follow-up for infants with chronic lung disease. In this model, which we refer to as community-based follow-up, medical management was coordinated by a nurse specialist, through frequent telephone contacts with the infants' primary caregiver. This model of follow up care was compared, in a randomized trial, with the more traditional model - multidisciplinary medical center-based care. We hypothesized that community-based care would lead to health and developmental outcomes similar to those observed with center-based care.

Condition Intervention Phase
Bronchopulmonary Dysplasia Prematurity Procedure: Care coordination by telephone contacts with a nurse Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Comparison of Two Models of Post-NICU Care for Preterm Infants With Neonatal Chronic Lung Disease

Resource links provided by NLM:


Further study details as provided by Wake Forest University Health Sciences ( Wake Forest University ):

Primary Outcome Measures:
  • Bayley Scales of Infant Development-Second Edition

Secondary Outcome Measures:
  • Growth through one year of age
  • Rehospitalizations in the first year of life
  • Vineland Adaptive Behavioral Scales

Estimated Enrollment: 150
Study Start Date: May 1996
Estimated Study Completion Date: August 2000
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 483 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants were eligible if they were born before 33 weeks gestational age, required supplemental oxygen at 36 weeks gestational age, and were discharged home after neonatal intensive care.

Exclusion Criteria:

  • Neonates who had major congenital anomalies and/ or had tracheostomy tubes were excluded. Also excluded were families in which the mother did not speak English, because the intervention depended on verbal communication with the nurse specialist, and families who lived more than 150 miles from our clinic because such families typically are referred to regional neonatal center closer to their home.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00314431


Locations
United States, North Carolina
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University
Investigators
Principal Investigator: Thomas M O'Shea, MD, MPH Wake Forest University Health Sciences
  More Information

Responsible Party: Wake Forest University
ClinicalTrials.gov Identifier: NCT00314431     History of Changes
Other Study ID Numbers: BG99547
R01HS007928 ( U.S. AHRQ Grant/Contract )
First Submitted: April 11, 2006
First Posted: April 13, 2006
Last Update Posted: November 6, 2017
Last Verified: April 2006

Keywords provided by Wake Forest University Health Sciences ( Wake Forest University ):
neonatal chronic lung disease
bronchopulmonary dysplasia
prematurity
telephone follow up
care coordination
children with special health care needs

Additional relevant MeSH terms:
Premature Birth
Bronchopulmonary Dysplasia
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases