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



Status:Recruiting
Conditions:Women's Studies, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases, Reproductive
Healthy:No
Age Range:Any
Updated:3/13/2019
Start Date:February 27, 2019
End Date:October 2022
Contact:Waldemar Carlo, MD
Email:wcarlo@peds.uab.edu
Phone:205-934-4680

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Randomized Controlled Trial of Home Therapy With Caffeine Citrate in Moderately Preterm Infants With Apnea of Prematurity

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.

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.

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
We found this trial at
16
sites
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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3040 East Cornwallis RoadTriangle
Durham, North Carolina 27705
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Durham, NC
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Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Providence, RI
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Rochester, NY
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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Salt Lake City, UT
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Albuquerque, New Mexico 87131
(505) 277-0111
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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Cincinnati, Ohio 45267
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Palo Alto, California 94304
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Philadelphia, Pennsylvania 19104
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