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Post-hospitalization Nursing Effectiveness (PHONE) Study

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. Identifier: NCT00314431
Recruitment Status : Completed
First Posted : April 13, 2006
Last Update Posted : November 6, 2017
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Brief Summary:
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 or disease Intervention/treatment Phase
Bronchopulmonary Dysplasia Prematurity Procedure: Care coordination by telephone contacts with a nurse Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
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
Study Start Date : May 1996
Study Completion Date : August 2000

Resource links provided by the National Library of Medicine

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

Secondary Outcome Measures :
  1. Growth through one year of age
  2. Rehospitalizations in the first year of life
  3. Vineland Adaptive Behavioral Scales

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

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.

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 identifier (NCT number): NCT00314431

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

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Responsible Party: Wake Forest University Identifier: NCT00314431    
Other Study ID Numbers: BG99547
R01HS007928 ( U.S. AHRQ Grant/Contract )
First Posted: April 13, 2006    Key Record Dates
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
telephone follow up
care coordination
children with special health care needs
Additional relevant MeSH terms:
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Bronchopulmonary Dysplasia
Premature Birth
Lung Diseases
Respiratory Tract Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Ventilator-Induced Lung Injury
Lung Injury
Infant, Premature, Diseases
Infant, Newborn, Diseases