Management of Apnea in Late Preterm and Term Infants
Status:
Withdrawn
Trial end date:
2021-05-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Boston Children's Hospital Boston Children’s Hospital