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Management of Apnea in Late Preterm and Term Infants

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ClinicalTrials.gov Identifier: NCT02408328
Recruitment Status : Not yet recruiting
First Posted : April 3, 2015
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Lawrence Rhein, Boston Children’s Hospital

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.


Condition or disease Intervention/treatment Phase
Apnea Drug: Caffeine citrate Device: Home monitor Other: Continued inpatient monitoring until apnea resolution Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Management of Apnea in Late Preterm and Term Infants
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

Arm Intervention/treatment
Active Comparator: Inpatient Observation
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
Continued inpatient monitoring until apnea resolution

Active Comparator: Caffeine and Outpatient Monitoring
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
Loading dose and continues use of caffeine until 44 weeks postmenstrual age

Device: Home monitor
Use of home monitor until 44 weeks postmenstrual age




Primary Outcome Measures :
  1. Respiratory Events [ Time Frame: Within 6 months of age ]
    respiratory-related acute care visits, emergency department visits, or rehospitalizations

  2. Parent Quality of Life [ Time Frame: Within 6 months of age ]
    Parent-reported quality of life (PedsQL and Impact on Family Scale)



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

As our intent will be to study infants for whom hospital stay is prolonged as a result of presumed apnea of prematurity, exclusion criteria will include: (1) comorbidities associated with an increased risk of apnea, including neurologic abnormalities such as congenital CNS malformations, seizures, or intracranial bleeds, anatomic abnormalities of the airway, significant congenital heart disease, residual lung disease requiring respiratory support, infectious disease including sepsis, pneumonia, or meningitis, chromosomal abnormalities, and drug withdrawal; (2) prolonged hospitalization for an indication other than apnea, bradycardia and/or oxygen desaturation such as feeding immaturity, temperature instability, or phototherapy; (3) transfer to an outside hospital; (4) provider concern with caregiver ability to safely operate and comply with home monitor use.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02408328


Contacts
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Contact: Lawrence Rhein, MD 617 355 3185 Lawrence.Rhein@childrens.harvard.edu

Sponsors and Collaborators
Boston Children’s Hospital

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Responsible Party: Lawrence Rhein, Assistant Professor of Pediatrics, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT02408328     History of Changes
Other Study ID Numbers: IRB-P00015842
First Posted: April 3, 2015    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Apnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Caffeine
Caffeine citrate
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents