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Moderately Preterm Infants With Caffeine at Home for Apnea (MoCHA) Trial (MoCHA)

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ClinicalTrials.gov Identifier: NCT03340727
Recruitment Status : Recruiting
First Posted : November 13, 2017
Last Update Posted : March 11, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
NICHD Neonatal Research Network

Brief 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.

Condition or disease Intervention/treatment Phase
Apnea of Prematurity Drug: Caffeine Citrate Drug: Placebo Phase 3

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Home Therapy With Caffeine Citrate in Moderately Preterm Infants With Apnea of Prematurity
Actual Study Start Date : February 27, 2019
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

Arm Intervention/treatment
Experimental: 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.
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 Comparator: 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.
Drug: 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.




Primary Outcome Measures :
  1. Number of days of hospitalization [ Time Frame: Randomization until discharge up to 48 wks PMA ]
    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.


Secondary Outcome Measures :
  1. The number of days to physiologic maturity after randomization [ Time Frame: Randomization until physiologic maturity up to 48 wks PMA ]
    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.

  2. PMA at discharge [ Time Frame: Randomization until discharge up to 48 wks PMA ]
    Post menstrual age at discharge up to 48 wks PMA, censoring at time of transfer or death.

  3. The number of all-cause hospital re-admissions [ Time Frame: Discharge until eight weeks after discharge up to 52 wks PMA ]
    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.

  4. The number of all-cause sick visits [ Time Frame: Discharge until eight weeks after discharge up to 52 wks PMA ]
    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.

  5. Death [ Time Frame: Randomization until eight weeks after discharge up to 52 wks PMA ]
    All cause mortalities

  6. Weight [ Time Frame: Randomization until discharge up to 48 wks PMA ]
    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

  7. Elevated Heart Rate [ Time Frame: Randomization until discharge up to 48 wks PMA ]
    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

  8. High Blood Pressure [ Time Frame: Randomization until discharge up to 48 wks PMA ]
    Treatment for high blood pressure initiated after randomization until discharge up to 48 wks PMA, with censoring at time of transfer or death

  9. Periods of NPO [ Time Frame: Randomization until discharge up to 48 wks PMA ]
    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.

  10. Reflux [ Time Frame: Randomization until discharge up to 48 wks PMA ]
    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)

  11. Significant Apnea [ Time Frame: Randomization until discharge up to 48 wks PMA ]
    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)

  12. Significant Bradycardia [ Time Frame: Randomization until discharge up to 48 wks PMA ]
    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)

  13. Arrhythmia [ Time Frame: Randomization until discharge up to 48 wks PMA ]
    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

  14. Seizures [ Time Frame: Randomization until discharge up to 48 wks PMA ]
    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).



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Ages Eligible for Study:   29 Weeks to 33 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03340727


Contacts
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Contact: Waldemar Carlo, MD 205-934-4680 wcarlo@peds.uab.edu
Contact: Abhik Das, PhD 301-230-4640

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Waldemar A Carlo, MD         
United States, California
Stanford University Not yet recruiting
Palo Alto, California, United States, 94304
Contact: Krisa P Van Meurs, MD         
United States, Georgia
Emory University Not yet recruiting
Atlanta, Georgia, United States, 30303
Contact: David Carlton, MD         
United States, Iowa
University of Iowa Not yet recruiting
Iowa City, Iowa, United States, 52242
Contact: Edward F Bell, MD         
United States, New Mexico
University of New Mexico Not yet recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Kristi L Watterberg, MD         
United States, New York
University of Rochester Not yet recruiting
Rochester, New York, United States, 14642
Contact: Carl T D'Angio, MD         
United States, North Carolina
RTI International Active, not recruiting
Durham, North Carolina, United States, 27705
Duke University Not yet recruiting
Durham, North Carolina, United States, 27710
Contact: Michael Cotten, MD         
United States, Ohio
Cincinnati Children's Medical Center Not yet recruiting
Cincinnati, Ohio, United States, 45267
Contact: Brenda Poindexter, MD         
Case Western Reserve University, Rainbow Babies and Children's Hospital Not yet recruiting
Cleveland, Ohio, United States, 44106
Contact: Michele C Walsh, MD MS         
Research Institute at Nationwide Children's Hospital Not yet recruiting
Columbus, Ohio, United States, 43205
Contact: Pablo Sanchez, MD         
United States, Pennsylvania
Univeristy of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Eric Eichenwald, MD         
United States, Rhode Island
Brown University, Women & Infants Hospital of Rhode Island Not yet recruiting
Providence, Rhode Island, United States, 02905
Contact: Abbot Laptook, MD         
United States, Texas
University of Texas Southwestern Medical Center at Dallas Not yet recruiting
Dallas, Texas, United States, 75235
Contact: Myra Myckoff, MD         
University of Texas Health Science Center at Houston Not yet recruiting
Houston, Texas, United States, 77030
Contact: Jon Tyson, MD MPH         
United States, Utah
University of Utah Not yet recruiting
Salt Lake City, Utah, United States, 84108
Contact: Bradley Yoder, MD         
Sponsors and Collaborators
NICHD Neonatal Research Network
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Waldemar Carlo, MD University of Alabama at Birmingham

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Responsible Party: NICHD Neonatal Research Network
ClinicalTrials.gov Identifier: NCT03340727     History of Changes
Other Study ID Numbers: NICHD-NRN-0056
UG1HD034216 ( U.S. NIH Grant/Contract )
UG1HD027904 ( U.S. NIH Grant/Contract )
UG1HD021364 ( U.S. NIH Grant/Contract )
UG1HD027853 ( U.S. NIH Grant/Contract )
UG1HD040689 ( U.S. NIH Grant/Contract )
UG1HD040492 ( U.S. NIH Grant/Contract )
UG1HD027851 ( U.S. NIH Grant/Contract )
UG1HD087229 ( U.S. NIH Grant/Contract )
UG1HD053109 ( U.S. NIH Grant/Contract )
UG1HD068278 ( U.S. NIH Grant/Contract )
UG1HD068244 ( U.S. NIH Grant/Contract )
UG1HD068263 ( U.S. NIH Grant/Contract )
UG1HD027880 ( U.S. NIH Grant/Contract )
UG1HD053089 ( U.S. NIH Grant/Contract )
UG1HD087226 ( U.S. NIH Grant/Contract )
U10HD036790 ( U.S. NIH Grant/Contract )
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Per NIH Data Sharing Plan

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by NICHD Neonatal Research Network:
Moderate preterm infant
Caffeine citrate

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Apnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Obstetric Labor Complications
Pregnancy Complications
Citric Acid
Sodium Citrate
Caffeine
Caffeine citrate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
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