Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT02408328 |
| Other study ID # |
IRB-P00015842 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
June 2020 |
| Est. completion date |
May 2021 |
Study information
| Verified date |
October 2019 |
| Source |
Boston Children’s Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Apnea is a common discharge-delaying diagnosis in the Newborn Intensive Care Unit. While it
is relatively more common in extremely premature infants, it also occurs frequently in late
preterm and even full term infants. Since the majority of all births include late preterm
infants and full term infants, the absolute number of late preterm and full term infants with
apnea remains significant. Evidence-based guidelines for the management of apnea in such
infants do not exist. Current management falls into two distinct but very different
categories. This study will compare these two distinct management strategies.
Our study will be a prospective, randomized pilot trial to provide data regarding (a)
feasibility for recruitment and study protocols and (b) provide preliminary data regarding
efficacy of both treatment arms.
Our primary objective will be to test the hypothesis that early discharge and outpatient
monitoring of late preterm and term infants with apnea of prematurity results in decreased
length of hospital stay, is safe, and results in improved patient satisfaction, as assessed
by the PedsQL questionnaire and Impact on Family Scale.
Our study population will include infants who meet the following criteria: (1) Born at
greater than or equal to 34 0/7 weeks gestation; (2) Are assigned a diagnosis of apnea,
bradycardia, and/or oxygen desaturations by the primary clinical team; (3) Have met all other
discharge criteria (i.e. feeding maturity, temperature regulation, etc.) so that
apnea/bradycardia/desaturation remains the final discharge issue for at least 7 days.
Infants enrolled in this research study will be randomized to in hospital observation versus
early discharge home with caffeine and a home monitor. Neither strategy is experimental as
both are currently utilized by neonatologists locally and nationally. A direct comparison of
the two treatments, however, has never been undertaken in a study. If an infant is assigned
to the in hospital group, they will remain in the hospital until an apnea free period of at
least 5 consecutive days has been established. Outpatient follow up will occur per unit
standard and typically includes a nursing visit and a doctor visit within 2-3 days of
discharge. Caregivers will be asked to complete 3 brief questionnaires at enrollment, at 1
month after hospital discharge, and at 6 months of age. Each questionnaire will ask about
topics such as satisfaction with hospital stay, quality of life, and numbers of acute care
visits and/or rehospitalizations. Alternatively, if an infant is assigned to the early
discharge group, caffeine will be given to the infant and if after a 3 day period no further
apnea is noted the infant will be discharged home with continued daily caffeine therapy by
mouth as well as a home monitor. Caffeine is a very commonly used drug in neonates and has an
excellent safety profile. Side effects are minimal and may infrequently consist of
gastroesophageal reflux. All caregivers will receive training on the use of a home monitor.
Initial outpatient follow up will occur per unit standard and typically includes a nursing
visit and a doctor visit within 2-3 days of discharge. Additionally, caregivers will be
contacted via telephone within 2 days to answer any questions or address any concerns
pertaining to apneic events, home monitor use, or caffeine therapy. Follow up in the
pulmonary clinic will be arranged at 42-43 weeks gestational age at which time caregivers
will be taught to determine the baseline frequency of monitor alarms on caffeine. At 43 weeks
corrected gestational age, caregivers will be instructed to discontinue caffeine therapy and
advised to contact the pulmonary clinic should alarm frequency increase. An outpatient
recorded oximetry study will be arranged at least 1 week after discontinuation of caffeine
therapy. Home pulse oximetry monitoring will be discontinued if no significant events are
recorded. Caregivers will be asked to complete 3 brief questionnaires at enrollment, at 1
month after discontinuation of the home monitor, and at 6 months of age. Each questionnaire
will ask about topics such as satisfaction with hospital stay, quality of life, and numbers
monitor alarms, acute care visits and/or rehospitalizations.
Description:
1. Study Design This is a prospective, randomized study. Our primary objective will be to
test the hypothesis that early discharge and outpatient monitoring of late preterm to
term infants with apnea of prematurity results in decreased length of hospital stay, is
safe and cost effective, and results in improved patient satisfaction, as assessed by
the PedsQL questionnaire and Impact on Family Scale.
2. Patient Selection and Inclusion/Exclusion Criteria
3. Description of Study Treatments or Exposures/Predictors The investigators will identify
all qualified infants who meet eligibility criteria for enrollment, and will obtain
informed consent at that time. Infants will not be randomized until their apnea,
bradycardia, and/or oxygen desaturation has been the sole remaining discharge criteria
for at least 7 days. Prior to randomization, but after the receipt of written informed
consent, the investigators will confirm that the primary clinical team has determined
that there are no alternate etiologies for the apnea/bradycardia/desaturation events,
based on diagnostic testing or clinical judgment.
Randomization will be stratified according to gestational age at birth to include two
broad categories as follows: 1) late preterm infants who are born between 34 0/7 and 36
6/7 weeks gestation (late preterm infants) and 2) term infants who are born at or
greater than 37 0/7 weeks gestation. Our aim will be to recruit at least 5 infants in
each treatment arm for both late preterm and full term infants.
Arm A will include continued inpatient monitoring of apnea, bradycardia, and/or
desaturation until an event free period of time (5 days per the current standard of care
at each participating institution) has been established and deemed appropriate for
discharge home per the discretion of the responsible provider. The protocol described in
Arm A is currently utilized as a standard of care for many infants locally and
nationally and is the first management option utilized at all participating
institutions. Arm B will include the initiation of caffeine treatment once randomization
has been established. Per current dosing guideline, patients will receive a one-time
loading dose of 20 milligrams per kilogram on day 1 with a daily maintenance dose
thereafter of 10 milligrams per kilogram. Monitoring of caffeine drug levels will not be
included in our protocol as the safety of caffeine treatment in neonates without
laboratory monitoring has been well established. After receiving the loading dose of
caffeine, infants will receive continued inpatient monitoring of
apnea/bradycardia/desaturation until an event free period of time (3 days per the
current standard of care at each participating institution) has been established and
deemed appropriate for discharge home per the discretion of the responsible provider.
Infants discharged home on caffeine therapy will receive instructions regarding use of a
home monitor, with alarms set to alarm for heart rate <80 or > 200 beats per minute, or
for oxygen saturation level < 90%. The protocol described in Arm B is currently utilized
as a standard of care for many infants locally and nationally as a secondary option
after observation alone has resulted in a prolonged inpatient stay due to persistent
apnea with all other discharge criteria having been met. In a recent retrospective
analysis of home monitor use, the investigators found that 1 in 20 infants with apnea of
prematurity were discharge home with a monitor.
Following discharge home, infants in Arm B will be contacted via telephone within 2 days
to answer any questions or address any concerns pertaining to apneic events, home pulse
oximeter use, or caffeine therapy. Follow up in the pulmonary clinic will be arranged at
42-43 weeks gestational age at which time caregivers will be taught to determine the
baseline frequency of monitor alarms on caffeine. At 43 weeks corrected gestational age,
caregivers will be instructed to discontinue caffeine therapy and advised to contact the
pulmonary clinic should alarm frequency increase. An outpatient recorded oximetry study
will be arranged at least 1 week after discontinuation of caffeine therapy. Home pulse
oximetry monitoring will be discontinued if no significant events, as previously
defined, are recorded.
Follow up after discharge in both treatment arms will otherwise proceed per unit
protocol and typically consists of a home visiting nurse within 2-3 days of hospital
discharge and a primary care provider appointment within 2-3 days of hospital discharge.
4. Data Collection Methods, Assessments, Interventions and Schedule (what assessments
performed, how often) For infants in both arms, parents will participate in a structured
questionnaire at enrollment, and 1 month after hospital discharge for patients in Arm A
and 1 month after discontinuation of home monitor use for patients in Arm B. The
investigators will also contact families at 6 months of age to determine
rehospitalization rates, and frequency of emergency department visits related to
respiratory issues.
