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Caffeine Treatment in in the Delivery Room (CAFROOM)

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ClinicalTrials.gov Identifier: NCT04044976
Recruitment Status : Not yet recruiting
First Posted : August 5, 2019
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
Carlo Dani, University of Florence

Brief Summary:

Background. In recent years, particular attention has been paid to all interventions that could help reduce the need for mechanical ventilation MV and, therefore, the risk of BPD. However, early application of non-invasive respiratory supports and early treatment with surfactant fail in 45-50% of cases. Failure frequently depends on the onset of apnea episodes and, therefore, it has been proposed to treat very preterm infants with caffeine already in the delivery room in the first min of life.

Hypothesis and objectives of the study. Our aim is to verify the hypothesis that it is possible to administer caffeine in the delivery room intravenously and enterally via an orogastric tube.

Study design. Infants 25-29 weeks of gestational age will be enrolled and will be randomized to receive 20 mg/kg of caffeine citrate intravenously, via the umbilical vein, or enterally, through an orogastric tube, within 10 min of birth. The dosage of plasma caffeine concentration will be performed 60+15 min after administration to measure its peak and 60+15 min before the next dose (5 mg/kg/day i.v.).

Endpoints. The primary endpoint will be the evaluation of the success rate of intravenous or enteral administration of caffeine in the delivery room. Secondary endpoints will be the evaluation of: number of infants in whom caffeine will be successfully administered by intravenous versus enteral route; number of infants where caffeine will be successfully administered that reached the therapeutic plasmatic range the first dose, confirming the success of the administration; comparison of caffeine blood level obtained with intravenous and enteral administration; frequency of successes in obtaining the therapeutic range after the second dose; frequency of MV within the first 72 hours of life in studied infants.

Statistical analysis. In the absence of previous studies to use as a reference and this study being a feasibility study, it was decided arbitrarily to study 20 infants treated in the delivery room with caffeine administered intravenously and 20 infants treated in the delivery room with caffeine administered enterally. The clinical characteristics of the two groups will be described by calculating the mean value and the standard deviation or the rate and percentage. The primary endpoint will be evaluated by calculating the percentage of cases in which caffeine will be successfully administered. The comparison between the number of infants in which caffeine will be successfully administered intravenously versus the enteral route and the comparison between the caffeine plasma level obtained with intravenous and enteral administration will be performed using the Student "t" test for continuous parametric variables, the Wilcoxon rank sum test for non-parametric continuous variables and the χ2 test for categorical variables. A p <0.05 will be considered as statistically significant.


Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome Drug: Caffeine Citrate Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Intervention Model Description: A cohort of preterm infants will be given caffeine in the delivery room
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Treatment With Caffeine of Very Preterm Infant in the Delivery Room: the CAFROOM Feasibility Study
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : August 31, 2021


Arm Intervention/treatment
Experimental: Treated infants
Infants who will receive caffeine in the delivery room.
Drug: Caffeine Citrate
Infants will receive 20 mg/kg of caffeine citrate intravenously, via the umbilical vein, or enterally, through an orogastric tube, within 10 min of birth.
Other Name: Caffeine




Primary Outcome Measures :
  1. Successful rate [ Time Frame: 10 minutes after birth ]
    Evaluation of the number of infants in which the administration of intravenous or enteral caffeine in the delivery room will occur successfully


Secondary Outcome Measures :
  1. Comparison of intravenous versus enteral route [ Time Frame: 10 minutes after birth ]
    Evaluation of number of infants in whom caffeine will be successfully administered by intravenous versus enteral route

  2. Caffeine administration and its therapeutic range [ Time Frame: 90 minutes after birth ]
    Number of infants in whom caffeine will be successfully administered that reached the therapeutic plasmatic range after the first dose

  3. Intravenous vs enteral caffeine administration and therapeutic range [ Time Frame: 90 minutes after birth ]
    Comparison of caffeine blood level obtained with intravenous and enteral administration

  4. Need of mechanical ventilation [ Time Frame: 72 hours of life ]
    Frequency of VM in studied infants



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Ages Eligible for Study:   up to 10 Minutes   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inborn infants
  • Infants with 25+0-29+6 weeks of gestational age
  • Infants who do not require MV in the delivery room

Exclusion Criteria:

  • Maternal consumption of caffeine before giving birth (> 2 cups of coffee in the 6 hours before birth)
  • Major congenital malformations
  • Chromosomal syndromes
  • Fetal hydrops
  • Inherited metabolic disorders

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): NCT04044976


Contacts
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Contact: Carlo Dani, MD 0039 347 9197560 cdani@unifi.it

Sponsors and Collaborators
University of Florence

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Responsible Party: Carlo Dani, Full Professor of Pediatrics, University of Florence
ClinicalTrials.gov Identifier: NCT04044976     History of Changes
Other Study ID Numbers: 02/2019
First Posted: August 5, 2019    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be collected in electronic sheet. These data will be available on request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data will become available at the end of the study.
Access Criteria: Access will be allowed on request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carlo Dani, University of Florence:
Caffeine
delivery room
preterm infant
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Tract Diseases
Infant, Newborn, Diseases
Lung Diseases
Respiration Disorders
Infant, Premature, Diseases
Caffeine
Caffeine citrate
Citric Acid
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