Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00314431 |
| Other study ID # |
BG99547 |
| Secondary ID |
R01HS007928 |
| Status |
Completed |
| Phase |
Phase 3
|
| First received |
April 11, 2006 |
| Last updated |
November 1, 2017 |
| Start date |
May 1996 |
| Est. completion date |
August 2000 |
Study information
| Verified date |
April 2006 |
| Source |
Wake Forest University Health Sciences |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
