Post-hospitalization Nursing Effectiveness (PHONE) Study

NCT00314431 | Completed Phase 3

• 2 other identifiers: BG99547R01HS007928
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchopulmonary Dysplasia; Prematurity

Keywords

neonatal chronic lung disease; bronchopulmonary dysplasia; prematurity; telephone follow up; care coordination; children with special health care needs

Outcome Measures

Primary Outcomes (1)

• Bayley Scales of Infant Development-Second Edition

Secondary Outcomes (3)

• Growth through one year of age

• Rehospitalizations in the first year of life

• Vineland Adaptive Behavioral Scales

Interventions

Care coordination by telephone contacts with a nurse PROCEDURE

Eligibility Criteria

• Age: 1 Day - 483 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University: lead

Study Sites (1)

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Premature Birth

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Thomas M O'Shea, MD, MPH

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2006
• First Posted: April 13, 2006
• Study Start: May 1, 1996
• Study Completion: August 1, 2000
• Last Updated: November 6, 2017

Record last verified: 2006-04

Locations

US (1)