Apnea of Prematurity Clinical Trial
— MoCHAOfficial title:
Randomized Controlled Trial of Home Therapy With Caffeine Citrate in Moderately Preterm Infants With Apnea of Prematurity
Verified date | February 2023 |
Source | NICHD Neonatal Research Network |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 800 |
Est. completion date | March 2023 |
Est. primary completion date | March 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 29 Weeks to 33 Weeks |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of New Mexico | Albuquerque | New Mexico |
United States | Emory University | Atlanta | Georgia |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Cincinnati Children's Medical Center | Cincinnati | Ohio |
United States | Case Western Reserve University, Rainbow Babies and Children's Hospital | Cleveland | Ohio |
United States | Research Institute at Nationwide Children's Hospital | Columbus | Ohio |
United States | University of Texas Southwestern Medical Center at Dallas | Dallas | Texas |
United States | Duke University | Durham | North Carolina |
United States | RTI International | Durham | North Carolina |
United States | University of Texas Health Science Center at Houston | Houston | Texas |
United States | University of Iowa | Iowa City | Iowa |
United States | Stanford University | Palo Alto | California |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Brown University, Women & Infants Hospital of Rhode Island | Providence | Rhode Island |
United States | University of Rochester | Rochester | New York |
United States | University of Utah | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
NICHD Neonatal Research Network | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of days of hospitalization | The number of days of hospitalization from randomization to discharge up to 48 weeks postmentrual age (PMA), with censoring at time of transfer or death. | Randomization until discharge up to 48 wks PMA | |
Secondary | The number of days to physiologic maturity after randomization | Physiologic maturity is defined as: 1) Temperature: out of the incubator for at least 48 hours with normal body temperature, 2) Feeding: oral feeding at a volume of at least 140 ml/kg/day or growing on less than 140 ml/kg/day for at least 48 hours and 3) Respiratory: apnea-free for at least 5 days. The number of days to physiologic maturity after randomization up to 48 wks PMA, with censoring at time of transfer or death. | Randomization until physiologic maturity up to 48 wks PMA | |
Secondary | PMA at discharge | Post menstrual age at discharge up to 48 wks PMA, censoring at time of transfer or death. | Randomization until discharge up to 48 wks PMA | |
Secondary | The number of all-cause hospital re-admissions | The number of all-cause re-admissions to the hospital within the first four weeks, second four weeks, and first eight weeks combined among those discharged from the hospital by 48 wks PMA. | Discharge until eight weeks after discharge up to 52 wks PMA | |
Secondary | The number of all-cause sick visits | The number of all-cause sick visits to urgent care, emergency rooms, or health care provider's office within the first four weeks, second four weeks, and first eight weeks combined among those discharged from the hospital by 48 wks PMA. | Discharge until eight weeks after discharge up to 52 wks PMA | |
Secondary | Death | All cause mortalities | Randomization until eight weeks after discharge up to 52 wks PMA | |
Secondary | Weight | Weight will be recorded at time of of birth, randomization and at status: discharge up to 48 wks PMA ,with censoring at time of transfer or death | Randomization until discharge up to 48 wks PMA | |
Secondary | Elevated Heart Rate | The number of days after randomization that infant had at least two consecutive heart rates >200 documented at least 3 hours apart (when infant not crying) until discharge up to 48 wks PMA, with censoring at time of transfer or death | Randomization until discharge up to 48 wks PMA | |
Secondary | High Blood Pressure | Treatment for high blood pressure initiated after randomization until discharge up to 48 wks PMA, with censoring at time of transfer or death | Randomization until discharge up to 48 wks PMA | |
Secondary | Periods of NPO | The number of episodes between randomization and status (discharge up to 48 wks PMA, with censoring at time of transfer or death) that infant was placed NPO for = 24 hours. | Randomization until discharge up to 48 wks PMA | |
Secondary | Reflux | The use of anti-reflux medications started between randomization and status (discharge up to 48 wks PMA, with censoring at time of transfer or death) | Randomization until discharge up to 48 wks PMA | |
Secondary | Significant Apnea | The number of days that significant apnea, as defined by receiving open label caffeine, CPAP for apnea or ventilatory support for apnea, is documented between randomization and status (discharge up to 48 wks PMA, with censoring at time of transfer or death) | Randomization until discharge up to 48 wks PMA | |
Secondary | Significant Bradycardia | The number of days that significant bradycardia, as defined by receiving treatment, is documented between randomization and status (discharge up to 48 wks PMA, with censoring at time of transfer or death) | Randomization until discharge up to 48 wks PMA | |
Secondary | Arrhythmia | The presence of documented and treated arrhythmias between randomization and status (discharge up to 48 wks PMA, with censoring at time of transfer or death), not due to tachycardia or bradycardia | Randomization until discharge up to 48 wks PMA | |
Secondary | Seizures | The onset of documented seizures, as defined by treating with anti-convulsants, between randomization and status (discharge up to 48 wks PMA, with censoring at time of transfer or death). | Randomization until discharge up to 48 wks PMA |
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