Management of Apnea in Late Preterm and Term Infants

NCT02408328 | Withdrawn Phase 2 DMC

• 1 other identifier: IRB-P00015842
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Apnea

Outcome Measures

Primary Outcomes (2)

• Respiratory Events

  respiratory-related acute care visits, emergency department visits, or rehospitalizations

  Within 6 months of age

• Parent Quality of Life

  Parent-reported quality of life (PedsQL and Impact on Family Scale)

  Within 6 months of age

Study Arms (2)

Inpatient Observation

ACTIVE COMPARATOR

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.

Other: Continued inpatient monitoring until apnea resolution

Caffeine and Outpatient Monitoring

ACTIVE COMPARATOR

Patients will receive a loading dose of caffeine on day 1 with a daily maintenance dose thereafter. Infants will then receive continued inpatient monitoring of apnea/bradycardia/desaturation until an event free period of time 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. Follow up in the pulmonary clinic will be arranged at 42-43 weeks gestational age. At 43 weeks corrected gestational age, caregivers will be instructed to discontinue caffeine therapy. 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.

Drug: Caffeine citrate; Device: Home monitor

Interventions

Caffeine citrate DRUG

Loading dose and continues use of caffeine until 44 weeks postmenstrual age

Caffeine and Outpatient Monitoring

Home monitor DEVICE

Use of home monitor until 44 weeks postmenstrual age

Caffeine and Outpatient Monitoring

Continued inpatient monitoring until apnea resolution OTHER

Continued inpatient monitoring until apnea resolution

Inpatient Observation

Eligibility Criteria

• Age: Up to 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Boston Children's Hospital: lead

MeSH Terms

Conditions

Apnea

Interventions

caffeine citrate

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: March 31, 2015
• First Posted: April 3, 2015
• Study Start: June 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: May 1, 2021
• Last Updated: October 24, 2019

Record last verified: 2019-10