Randomized Controlled Trial of Home Therapy With Caffeine Citrate in Moderately Preterm Infants With Apnea of Prematurity
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 827
- 试验地点
- 16
- 主要终点
- Number of Days Between Randomization and Hospital Discharge
研究概览
简要总结
The objective of this study is to evaluate the effect of continuing treatment with caffeine citrate in the hospital and at home in moderately preterm infants with resolved apnea of prematurity on days of hospitalization after randomization.
详细描述
Study subjects will be patients in the NICU at one of the participating hospitals at a Neonatal Research Network site. Infants who meet the eligibility criteria will be randomized to either caffeine citrate at 10 mg/kg/dose or placebo (equal volume of all the excipients except for the active ingredient, caffeine citrate) to be given daily beginning within 72 hours of open label caffeine discontinuation. The infant may still require hospitalization for observation after discontinuation of open label caffeine or for other discharge issues such as temperature control or feeding tolerance.
Once deemed ready for discharge, infants will be continued at home on the same dose of caffeine citrate or placebo for the first 28 days after hospital discharge. On the day of discharge, the parent will be supplied with 28 numbered vials with oral caffeine citrate (intervention group) or placebo at an equivalent volume (placebo group).
The parents will be educated by the research nurse, discharge nurse, physician, or pharmacist on storage and administration of study medication. A member of the research team will contact the parents to obtain post-discharge information within 72 hours after discharge, once a week for the first 4 weeks, and biweekly during the weeks 5 to 8 after discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 29 Weeks 至 33 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inborn and outborn infants of 29 0/7 to 33 6/7 weeks gestational age at birth
- •admitted to hospitals of the NICHD NRN who, are at time of enrollment:
- •≤35 6/7 weeks post-menstrual age at the time of randomization
- •Receiving caffeine with plan to discontinue treatment or just discontinued caffeine treatment
- •Receiving feeds at a volume of ≥120 ml/kg/day by oral and/or tube feeding
- •Ability to start study medication within 72 hours after stopping caffeine
排除标准
- •On respiratory therapy (oxygen more than room air equivalent for high altitude sites, nasal cannula, continuous positive pressure ventilation, and/or mechanical ventilation)
- •Infants who would otherwise be discharged home on apnea monitor due to underlying disease or family history, including history of a sibling with sudden infant death syndrome
- •Parental request for apnea monitor
- •Congenital heart disease other than atrial septal defect, ventricular septal defect, or patent ductus arteriosus
- •Neuromuscular conditions affecting respiration
- •Major congenital malformation and/or genetic disorder
- •Plans to transfer to a non-NRN site before discharge
- •Unable to obtain parental or guardian consent
研究组 & 干预措施
Caffeine Citrate
Caffeine citrate at 10 mg/kg/dose (5 mg/kg caffeine base) daily, in hospital. Infants will continue at home on the same dose of caffeine citrate for the first 28 days after hospital discharge.
干预措施: Caffeine Citrate (Drug)
Placebo
Placebo contains all of the excipients except for the active ingredient, caffeine citrate, (a volume equivalent to 10 mg/kg of caffeine citrate) and given daily. Infants will be continued at home on the same dose of placebo for the first 28 days after hospital discharge.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Days Between Randomization and Hospital Discharge
时间窗: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
The number of days between randomization and hospital discharge. This outcome is censored at 48 weeks PMA and at time of transfer or death.
Number of Sick Visits Related to Apneic or Apparent Life-threatening Events Within First 4 Weeks Post-discharge
时间窗: Discharge through 4 weeks post-discharge
Number of sick visits related to apneic or apparent life-threatening events within first 4 weeks post-discharge MEASTYPE=SEC
次要结局
- The Number of Days to Apnea/ Bradycardia Free for 5 Consecutive Days(Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA)
- The Number of Days to Oral Feeds >140 ml/kg/Day or Growing on Less Than 140 ml/kg/Day for at Least 48 Hours(Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA)
- Post-menstrual Age at Discharge(Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA)
- The Number of Days After Randomization Until Status That Infant Had at Least Two Consecutive Heart Rates >200 Documented at Least 3 Hours Apart(Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA)
- The Number of Days to Physiologic Maturity After Randomization(Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA)
- Weight Gain From Randomization Until Status(Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA)
- Treatment for High Blood Pressure(Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA)
- The Number of Days to When Out of Incubator for 48 Hours: When Maintained Stable Temp for 48 Hrs(Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA)
- All-cause Mortality(Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA)
- Number of All-cause Readmissions Within First 4 Weeks Post-discharge(Discharge through 4 weeks post-discharge)
- Number of All-cause Readmissions Within Second 4 Weeks Post-discharge(4 weeks through 8 weeks post-discharge)
- Number of All-cause Readmissions Within First 8 Weeks Post-discharge(Discharge through 8 weeks post-discharge)
- Number of All-cause Sick Visits, Urgent Care, Emergency Rooms, or Health Care Provider%'s Office, Within First 4 Weeks Post-discharge(Discharge through 4 weeks post-discharge)
- Number of All-cause Sick Visits, Urgent Care, Emergency Rooms, or Health Care Provider%'s Office, Within Second 4 Weeks Post-discharge(4 weeks through 8 weeks post-discharge)
- Number of All-cause Sick Visits, Urgent Care, Emergency Rooms, or Health Care Provider%'s Office, Within First 8 Weeks Post-discharge(Discharge through 8 weeks post-discharge)
- Number of Sick Visits Related to Apneic or Apparent Life-threatening Events Within Second 4 Weeks Post-discharge(4 weeks through 8 weeks post-discharge)
- Number of Sick Visits Related to Apneic or Apparent Life-threatening Events Within First 8 Weeks Post-discharge(Discharge through 8 weeks post-discharge)
- The Number of Episodes Between Randomization and Status That Infant Was Placed NPO for >= 24 Hours(Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA)
- Use of Anti-reflux Medications(Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA)
- Number of Days That Significant Apnea/Bradycardia(Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA)