Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03340727
Other study ID # NICHD-NRN-0056
Secondary ID UG1HD034216UG1HD
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date February 27, 2019
Est. completion date March 2023

Study information

Verified date February 2023
Source NICHD Neonatal Research Network
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Caffeine Citrate
The study intervention is caffeine citrate given once daily at 10 mg/kg/day. It is given orally, before hospital discharge and 28 days after discharge.
Placebo
The study intervention is placebo given once daily at a volume equivalent to 10 mg/kg of caffeine citrate. It is given orally, before hospital discharge and 28 days after discharge.

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
NICHD Neonatal Research Network Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT03670732 - CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure N/A
Terminated NCT02524249 - Early Versus Late Caffeine for ELBW Newborns N/A
Completed NCT03292562 - A Comparison of Methods of Discontinuing Nasal CPAP in Premature Infants <30 Weeks Gestation N/A
Recruiting NCT05298748 - The Effect of Womb Recordings on Maturation of Respiratory Control in Preterm Infants N/A
Recruiting NCT05968586 - Non-Invasive Neurally Adjusted Ventilatory Assist (NAVA) Prone vs Supine in Premature Infants N/A
Active, not recruiting NCT02641249 - Non-invasive Intervention for Apnea of Prematurity N/A
Terminated NCT01911182 - Inhalation of Low Concentration of CO2 in Preterm Infants Not Responding to Caffeine for the Treatment of Apnea Phase 2/Phase 3
Completed NCT00182312 - Caffeine for Apnea of Prematurity (CAP) Phase 3
Recruiting NCT03651648 - Apnea Treatment in Premature Infants Using an Automatic Vibro-tactile Stimulator Triggered by the Detection of Apnea-bradycardia. N/A
Recruiting NCT03298347 - Caffeine for Preterm Infants With Apnea of Prematurity(AOP) N/A
Completed NCT01020357 - Caffeine for Apnea of Prematurity-Sleep (CAP-S) Study Phase 3
Completed NCT00809055 - MRI and Neurodevelopment in Preterm Infants Following Administration of High-Dose Caffeine Phase 4
Completed NCT03298035 - A Comparison of Non-invasive Ventilation Methods Used to Prevent Endotracheal Intubation Due to Apnea in Very Low Birth Weight Infants N/A
Completed NCT03695900 - Arterial Oxygen Saturation on Ventilatory Stability in Extremely Premature Infants N/A
Completed NCT04327466 - Effect of High Frequency Oscillatory Highflow Nasal Cannula on Desaturations and Bradycardia in Preterm Infants N/A
Not yet recruiting NCT06374147 - "Prapela® SVS Incubator Pad for Apnea of Prematurity N/A
Completed NCT04868565 - Target Weaning Oxygen to Determine Cafffeine Duration for AOP Phase 4
Terminated NCT00482040 - Randomized Trial Investigating Four Nasal CPAP Systems in the Management of Apnea of Prematurity N/A
Not yet recruiting NCT06292299 - The PARS Study: Paediatric Advanced Respiratory Service Study - An Observational Diagnostic Feasibility Study
Completed NCT05393817 - Caffeine Citrate Use and Electronic Activity of the Diaphragm (EDI) Changes