Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn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Status Withdrawn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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date May 2021
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 3 Months
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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
Other:
Continued inpatient monitoring until apnea resolution
Continued inpatient monitoring until apnea resolution

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Boston Children’s Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Respiratory Events respiratory-related acute care visits, emergency department visits, or rehospitalizations Within 6 months of age
Primary Parent Quality of Life Parent-reported quality of life (PedsQL and Impact on Family Scale) Within 6 months of age
See also
  Status Clinical Trial Phase
Completed NCT02580526 - Comparison of Mask Ventilation Techniques in Patients Requiring General Anesthesia N/A
Completed NCT02627001 - Nu-Mask Intraoral Airway Device Versus Conventional Bag Valve Mask Ventilation Crossover Trial Phase 4
Recruiting NCT01825473 - Study of Erythromycin in GER-Associated Apnea of the Newborn N/A
Completed NCT02103777 - High Versus Low Dose of Caffeine for Apnea of Prematurity Phase 3
Completed NCT00950287 - Detection of Neonatal Bradycardia N/A
Recruiting NCT00382876 - Identifying the Relative Change in Ventilation in Newborns With Placement in Car Bed or Car Seat N/A
Completed NCT00369759 - An Epidemiological Study to Evaluate the RSV-Associated Lower Respiratory Track in Infections in Infants N/A
Completed NCT04084535 - Effects of High Intensity Interval Training (HIIT) vs. Inspiratory Muscle Training on the Recovery After a Maximal Apnea. N/A
Recruiting NCT02968797 - Clinical Comparative Study to Validate Performance of SafeSed Prototype Monitoring Endoscopy Under Sedation
Completed NCT02554110 - Peripheral Nerve Stimulation to Reduce Hypoxic Events N/A
Not yet recruiting NCT04366414 - Breathing Protocol in Breath-hold Divers N/A
Completed NCT05124093 - The Effect of High-flow Nasal Oxygen Flow Rate on Gas Exchange During Apnoea N/A
Recruiting NCT01994785 - Use of Capnography in EGD and Colonoscopy With Moderate Sedation. N/A
Completed NCT01435486 - Caffeine Citrate for the Treatment of Apnea Associated With Bronchiolitis in Young Infants N/A
Completed NCT01852929 - Sleep Apnea and Visual Perceptual Skill Learning N/A
Completed NCT00389909 - Dosing Chart for Calculating the First Dose of Doxapram in Premature Infants Phase 4
Completed NCT00188968 - Randomized Trial of Nasal Continuous Positive Airway Pressure or Synchronized Nasal Ventilation in Premature Infants. Phase 3
Not yet recruiting NCT05396274 - High Flow Nasal Oxygen Therapy Undergoing Colonoscopy N/A
Completed NCT02800213 - Ventilation Using a Bag Valve Mask With Supplemental External Handle N/A
Completed NCT02375230 - MRSOPA-Drills to Improve Mask Ventilation in the Delivery Room N/A