Post-hospitalization Nursing Effectiveness (PHONE) Study

Related Clinical Trial
Phase 1 Trial of Inhaled Tobramycin in BPD The Budesonide in Babies (BiB) Trial Follow-up Results of Newborns With Tracheostomy Safety of Sildenafil in Premature Infants With Severe Bronchopulmonary Dysplasia Prolonged Outcomes After Nitric Oxide (PrONOx) A Study of Tobacco Smoke and Children With Respiratory Illnesses Delivery Room CPAP in Extremely Low Birth Weight Infants Dexamethasone Therapy in VLBW Infants at Risk of CLD Palivizumab for Prevention of Severe Respiratory Syncytial Virus Infection in Russian Children Estimating Length of Endotracheal Tube Insertion Using Gestational Age or Nasal-Tragus Length in Newborn Infants MRI as a Means to Measure Lung Function: Non-Invasive Imaging in Neonates and Children Seattle-PAP Bubble Nasal CPAP and Work of Breathing High Frequency Oscillatory Ventilation Combined With Intermittent Sigh Breaths: Effects on Blood Oxygenation and Stability of Oxygenation Comparing Two Different Modes of Ventilation in Pretem Neonates Bilevel VG and PRVC High Frequency Ventilation in Premature Infants (HIFI) Early Caffeine in Preterm Neonates High Frequency Oscillatory Ventilation Combined With Intermittent Sigh Breaths: Effects on Lung Volume Monitored by Electric Tomography Impedance. Functional and Lymphocytic Markers of Respiratory Morbidity in Hyperoxic Preemies Vitamin A Supplementation for Extremely-Low-Birth-Weight Infants Non-invasive Respiratory Support in Preterm Infants Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates Randomized Trial of Nasal Continuous Positive Airway Pressure or Synchronized Nasal Ventilation in Premature Infants. The Effect of Surfactant Dose on Outcomes in Preterm Infants With RDS Work of Breathing During Non-invasive Ventilation in Premature Neonates Inhaled Nitric Oxide for Preventing Chronic Lung Disease in Premature Infants Intratracheal Budesonide/Surfactant Prevents BPD Bronchopulmonary Disease (BPD) Patient Registry Premature Birth and Its Sequelae in Women Inhaled NO in Prevention of Chronic Lung Disease The Effects of Position on the Oxygenation Instability of Premature Infants as Documented by SpO2 Histograms Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide Continuous Positive Airway Pressure Via Binasal Prong vs Nasal Mask: a Randomised Controlled Trial Randomized Trial of Hydrocortisone in Very Preterm High-Risk Infants Early NCPAP Before Surfactant Treatment in Very Preterm Infants With RDS Exosurf Neonatal and Survanta for Treatment of Respiratory Distress Syndrome Continuous Versus Intermittent Bolus Feeding in Very Preterm Infants – Effect on Respiratory Morbidity Feasibility and Impact of Volume Targeted Ventilation in the Delivery Room Growth of Airways and Lung Tissues in Premature and Healthy Infants Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants Assessment of Lung Structure and Function of Infants Born Prematurely Post-hospitalization Nursing Effectiveness (PHONE) Study Assessment of the Pulmonary Diffusion Capacity in Healthy Infants and Infants With Chronic Lung Disease NCPAP + Heliox as a Treatment for Infant Respiratory Distress Syndrome (RDS) Neurotrophin Expression in Infants as a Predictor of Respiratory and Neurodevelopmental Outcomes Inhaled Beclomethasone to Prevent Chronic Lung Disease Work of Breathing in Premature Infants at Discharge Efficacy of Recombinant Human Clara Cell 10 Protein (rhCC10) Administered to Premature Neonates With Respiratory Distress Syndrome Hydrocortisone for BPD Clinic Features and Outcome of BPD (SGBPD) Neolifes Heart – Pulmonary Hypertension in Preterm Children Thrombocytopoiesis and Platelet Homeostasis in Infants With Bronchoplumonary Dysplasia Management of Hyponatremia in Preterm Infants on Diuretics Steroids and Surfactant in Extremely Low Gestation Age Infants Dose Escalation Trial Respiratory Outcome at Adolescence of Very Low Birthweight Infants Surfactant Administration During Spontaneous Breathing Determining the Effect of Spironolactone on Electrolyte Supplementation in Preterm Infants With Chronic Lung Disease Developmental Sequelae of Severe Chronic Lung Disorders Long-term Safety and Efficacy Follow-up Study of PNEUMOSTEM® in Patients Who Completed PNEUMOSTEM® Phase-I Study Indoor Air Quality and Respiratory Morbidity in School-Aged Children With BPD Study of Nasal Ventilation In Preterm Infants To Decrease Time on The Respirator Improving Prematurity-Related Respiratory Outcomes at Vanderbilt Study of Inhaled Nitric Oxide (iNO) and Respiratory Outcomes in Late Preterm Infants Follow-up Study of Safety and Efficacy in Subjects Who Completed PNEUMOSTEM® Phase II (MP-CR-012) Clinical Trial Follow-up Safety and Efficacy Evaluation on Subjects Who Completed PNEUMOSTEM® Phase-II Clinical Trial Tidal Neonatal NO, Vitamins A and D, and Infant Lung Disease – The AD-ON Study Nasal Mask and Prong Use in Non-invasive Ventilation for Newborns Azithromycin in the Prevention of Lung Injury in Premature Newborn Randomized Control Trial: Synchronized Non-invasive Positive Pressure Ventilation Versus Non Synchronized Non Invasive Positive Pressure Ventilation in Extremely Low Birth Weight Infants Neurally Adjusted Ventilatory Assist vs Proportional Assist Ventilation MRI in BPD Subjects A Safety Study of IV Stem Cell-derived Extracellular Vesicles (UNEX-42) in Preterm Neonates at High Risk for BPD Hypercapnia and Its Association With Long-term Respiratory Morbidities in Premature Infants With Chronic Lung Disease Early Versus Late Caffeine for ELBW Newborns Assessment of Lung Aeration at Birth MRI of Lung Structure and Function in Preterm Children BPD Saturation TARgeting Use of Human Milk Cream to Decrease Length of Stay in Extremely Premature Infants Effect of Synchronized vs. Continuous HFNC Using NAVA on WOB in Infants With BPD Antecedents of Bronchopulmonary Dysplasia Pulmonary Outcomes of Bronchopulmonary Dysplasia in Young Adulthood Aerosolized Albuterol Use in Severe BPD Late Sequelae of Bronchopulmonary Dysplasia Montelukast in Very Low Birthweight Infants Preterm Infant Inhaled Albuterol Dosing 129Xe MRI in Pediatric Population With BPD Investigation of Polymorphisms in Bronchopulmonary Dysplasia In Turkish Population Pulmonary MRI of Ex-preterm Children With and Without BPD To Understand Risk of Emphysematous Changes Comparison of Classification Standards of BPD in Premature Infants Inhaled Corticosteroids for Treatment of Bronchopulmonary Dysplasia Safety of Sildenafil in Premature Infants Phase II Pilot Study of Early Cortisol Replacement to Prevent Bronchopulmonary Dysplasia Intratracheal Umbilical Cord-derived Mesenchymal Stem Cells for Severe Bronchopulmonary Dysplasia Phase III Randomized, Double-Blind Study of Dexamethasone Vs Dexamethasone/Methylprednisolone Vs Placebo for Bronchopulmonary Dysplasia Impact of an Exercise Program for Children Aged 4 to 6 Years With Bronchopulmonary Dysplasia Trial II of Lung Protection With Azithromycin in the Preterm Infant Forced Oscillometry in Infants With Bronchopulmonary Dysplasia The Efficacy and Safety of Montelukast Sodium in the Prevention of Bronchopulmonary Dysplasia L-citrulline and Pulmonary Hypertension Associated With Bronchopulmonary Dysplasia The Role of Anti-Reflux Surgery for Gastroesophageal Reflux Disease in Premature Infants With Bronchopulmonary Dysplasia Enteral Zinc to Improve Growth in Infants at Risk for Bronchopulmonary Dysplasia Fluid Filled Lung Oxygenation Assistance Trial Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia Predictors of Pulmonary Hypertension Risk in Premature Infants With Bronchopulmonary Dysplasia Exogenous Surfactant in Very Preterm Neonates in Prevention of Bronchopulmonary Dysplasia Follow-Up Study of Safety and Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia Risk Factors in Bronchopulmonary Dysplasia (Newborn Lung Project) Pilot Study of Topical Steroid for Prevention of Chronic Lung Disease in Extremely Premature Infants. Bronchopulmonary Dysplasia: From Neonatal Chronic Lung Disease to Early Onset Adult COPD Gastrin-Releasing Peptide and Bronchopulmonary Dysplasia Benchmarking Initiative to Reduce Bronchopulmonary Dysplasia Physiologic Definition of Bronchopulmonary Dysplasia Safety and Efficacy of PNEUMOSTEM® in Premature Infants at High Risk for Bronchopulmonary Dysplasia (BPD) – a US Study Inhaled Nitric Oxide for Pulmonary Hypertension and Bronchopulmonary Dysplasia Human Mesenchymal Stem Cells For Infants At High Risk For Bronchopulmonary Dysplasia SURFAXIN® Treatment for Prevention of Bronchopulmonary Dysplasia (BPD) in Very Low Birth Weight (VLBW) Infants. Safety of Furosemide in Premature Infants at Risk of Bronchopulmonary Dysplasia (BPD) Mesenchymal Stem Cells for The Treatment of Bronchopulmonary Dysplasia in Infants p16Ink4a in Bronchopulmonary Dysplasia in Children Transpyloric Feeding in Severe Bronchopulmonary Dysplasia Follow-Up Study of Mesenchymal Stem Cells for Bronchopulmonary Dysplasia Phase 1 Intravenous Citrulline for the Prevention of Bronchopulmonary Dysplasia in Preterm Infants Epidemiological Study for Bronchopulmonary Dysplasia (BPD) in China PREMILOC Trial to Prevent Bronchopulmonary Dysplasia in Very Preterm Neonates Stem Cells for Bronchopulmonary Dysplasia Hydrotherapy in Premature Infants With Bronchopulmonary Dysplasia Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants Prospective Study on Plasma Pro-endothelin-1 in Predicting Bronchopulmonary Dysplasia Interest of Pulmonary Ultrasound to Predict Evolution Towards Bronchopulmonary Dysplasia in Premature Infants at Gestational Age Less Than or Equal to 34 Weeks of Gestation Safety and Efficacy Evaluation of PNEUMOSTEM® Treatment in Premature Infants With Bronchopulmonary Dysplasia Inhaled Extra-fine Hydrofluoalkane-beclomethasone (QVAR) in Premature Infants With Bronchopulmonary Dysplasia (BPD) Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia Study to Justify Steroid Use in Preterm Neonates to Prevent Bronchopulmonary Dysplasia Efficacy of Adding Budesonide to Poractant Alfa to Prevent Bronchopulmonary Dysplasia. Human Mesenchymal Stem Cells For Bronchopulmonary Dysplasia Human Mesenchymal Stem Cells For Moderate and Severe Bronchopulmonary Dysplasia Genetic Susceptibility for Bronchopulmonary Dysplasia in Preterm Infants Respiratory Management of Preterm Infants and Bronchopulmonary Dysplasia

Brief Title

Post-hospitalization Nursing Effectiveness (PHONE) Study

Official Title

Randomized Comparison of Two Models of Post-NICU Care for Preterm Infants With Neonatal Chronic Lung Disease

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.
    

Detailed Description

      METHODS Study design A randomized equivalence trial was designed to compare community-based
      follow up with medical-center based follow up. The primary outcome was assessed at one year
      adjusted age.

      Study participants Infants were recruited in five neonatal intensive care units in northwest
      North CArolina. These were the only sites providing neonatal intensive care in a
      twenty-county region in northwest North Carolina. Infants were born between March 1996 and
      September 1999. Infants were eligible for the study 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. 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.

      Randomization A randomization list was prepared by a biostatistician who was not involved in
      data collection or clinical care of the infants. Lists of randomization assignments, which
      were kept in a sealed envelope in a locked drawer, were prepared for each of the five sites
      at which participants were recruited. Randomization assignments were made in blocks sizes of
      two and four. Once a study participant arrived home from the neonatal intensive care unit, a
      research assistant uncovered the next assignment on the randomization list, which was kept in
      a sealed envelope in a locked drawer.

      Intervention If the family did not have telephone service at the time of the infant's
      discharge, a telephone was installed at no cost to the family, within one week of the
      infant's discharge from the hospital. Research funds were used to reimburse all families for
      the cost of local phone service for the duration of the study. Families assigned to either
      intervention could contact the nurse specialist on a toll-free long distance line with voice
      mail which recorded messages when the phone was not attended.

      The intervention team consisted of two neonatologists, a pediatric social worker, and a nurse
      specialist.

      Community-based follow up Telephone contacts were made to the infants' primary caregiver by
      the nurse specialist twice weekly in the first month after discharge, weekly in months two
      through four, and monthly thereafter until the infant attained 12 months adjusted age. At
      each telephone contact, the nurse used a semi-structured format to inquire about the infant's
      health, community resources utilized by the infant, and potential stressors and sources of
      support for the family. She also inquired about the infant's medications and feedings. If she
      judged the infant would benefit from a change in medical management, additional assessments
      or a subspecialty referral, she discussed the proposed change with one of the two study
      neonatologists. If there was agreement, the recommendation was communicated to the family and
      the infant's primary care provider. The nurse specialist also coordinated care for the infant
      by communicating with home health nurses, public health nurses, early intervention
      specialists, physical therapists, and pediatric sub-specialists.

      Medical center-based follow up For infants who were discharged home on supplemental oxygen,
      the nurse specialist made a home visit 1 to 2 weeks after discharge. During this visit, the
      nurse specialist obtained interim medical history, performed physical assessment including
      pulse oximetry and body weight, reviewed discharge instructions regarding medication dosage
      and use of durable medical equipment, and answered caregiver's questions about the infant's
      care. If the nurse specialist had concerns about the medical condition of the infant, she
      made changes to the plan of care after consultation with the study neonatologist.

      All infants assigned to the center-based care group were seen in the regional, high-risk
      infant multidisciplinary clinic at Wake Forest University School of Medicine. The first
      clinic visit occurred approximately one month after their discharge. A multidisciplinary team
      consisting of the social worker, the nurse specialist and the neonatologist obtained detailed
      interim medical history (feeding, respiratory status, medication history, illnesses and
      health-services utilization) and performed a complete physical examination. Family stressors
      and resources were discussed. All infants were scheduled for visits at four, eight, and
      twelve months adjusted age. In addition, infants who were using supplemental oxygen were seen
      at an interval of 1-2 months until all of the following criteria were met: 1) their growth
      rate was 15-30 grams/day, 2) they were no longer using supplemental oxygen or other
      medications, and 3) they were no longer using a home apnea monitor. At each clinic visit, the
      infant and parent or guardian were seen individually by the clinic social worker, the nurse
      specialist for this project, and one of the two neonatologists who conferred as a group and
      developed a plan of care. This plan was communicated to the family by the nurse specialist.

      Communication with primary care providers Within 24 hours after randomization, the principal
      investigator called the infants' primary care providers to inform them about the study design
      and that the parents have consented to participate in the study. In the case of infants
      randomized to community-based care, the primary care provider was given the choice of making
      the decisions about changes in medical care independently or jointly with the nurse
      specialist. A copy of a protocol for management of infants with CLD, developed by the study
      team was mailed to each primary care provider. After each clinic visit (for the center-based
      group) the primary care provider received a letter describing findings, impressions, and
      recommendations. Contacts with the primary care physicians of infants randomized to
      community-based care occurred whenever the nurse specialist believed that a change in care
      was indicated.

      Outcomes assessed during the first year Self-administered questionnaires were used to assess
      psychosocial status of the family, healthcare utilization and healthcare expenses at
      baseline, one, four, seven and eleven months. Each time the family completed study
      questionnaires and when home visits were made, families were given twenty dollars as
      compensation. At eleven months, a research assistant conducted a home visit and assessed the
      home using the Caldwell HOME Inventory,27 and the parent-infant interaction using a scale
      developed by Holditch and Miles.28 Only results of rehospitalization rates during the first
      year will be presented in this paper.

      Outcomes assessed at one year adjusted age All children were evaluated at one year adjusted
      age at a Development Evaluation Clinic dedicated solely to developmental assessments of
      high-risk infants. The primary outcome, the Bayley Scales of Infant Development-Second
      Edition (BSID-2) Mental Developmental Index (MDI)I, and two secondary outcomes - the BSID
      Pyschomotor Developmental Index (PDI) and the Vineland Adaptive Behavioral Scales (VABS) were
      assessed by child psychologists or psychology graduate students supervised by a child
      psychologist, who were not aware of the child's intervention group or medical history. After
      the testing was completed, the psychologist was informed of the infant's gestational age at
      birth, so that the BSID scores could be corrected for the degree of prematurity. The BSID MDI
      is a widely used and validated developmental assessment tool to measure cognitive development
      in the first two years of life. The BSID PDI measures fine and gross motor development.29 The
      population mean for both the scores is 100 with a standard deviation of 15. Higher score on
      BSID MDI and PDI represents better cognitive and motor functioning respectively.30 When the
      BSID MDI/ PDI score was less than 50, then the score was extrapolated as described
      previously.31

      The Vineland Adaptive Behavior Scales are a parent-reported measure of child adaptive
      development. The scale assesses four domains of adaptive development: communication, daily
      living skills, socialization, and motor skills. The overall Adaptive Behavior Composite (ABC)
      is a standard score based on the child's age, with higher scores representing better adaptive
      functioning. Population mean for ABC is 100 and the standard deviation is 15.32

      Anthropometric measurements were performed by a neonatologist, who was aware of the infants'
      intervention assignment, using a pediatric scale for weight, a length board for length, and a
      tape measure for head circumference. Growth delay was defined as weight for length less than
      5th percentile at one year adjusted age. At 1 year follow-up, a research assistant reviewed
      each child's clinic chart and noted whether any of the following health conditions or receipt
      of health-services: cerebral palsy, blindness, hearing impairment, seizure disorder, oxygen
      requirement, need for tracheostomy tube and ventriculo-peritoneal shunt.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Bayley Scales of Infant Development-Second Edition

Secondary Outcome

 Growth through one year of age

Condition

Bronchopulmonary Dysplasia

Intervention

Care coordination by telephone contacts with a nurse


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

150

Start Date

May 1996

Completion Date

August 2000


Eligibility 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.
      

Gender

All

Ages

N/A - 483 Days

Accepts Healthy Volunteers

No

Contacts

Thomas M O'Shea, MD, MPH, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00314431

Organization ID

BG99547

Secondary IDs

R01HS007928

Responsible Party

Sponsor

Study Sponsor

Wake Forest University


Study Sponsor

Thomas M O'Shea, MD, MPH, Principal Investigator, Wake Forest University Health Sciences


Verification Date

April 2006