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Early Versus Routine Caffeine Administration in Extremely Preterm Neonates

NCT ID: NCT01783561

Last Updated: 2018-12-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-05-31

Brief Summary

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Premature infants are at risk of having pauses in breathing, or apneas, due to their immaturity. Premature infants are routinely given caffeine, a respiratory stimulant, on the first day of life to prevent apneas. However, if they continue to have apneas, they may require a breathing tube to be placed in the trachea. There are risks to having a breathing tube, so it would be beneficial to avoid it if possible. If caffeine is given earlier, it may decrease the need for a breathing tube. Some studies also suggest that caffeine may also improve heart function which may prevent low blood pressure if given early.

Detailed Description

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This goal of this observational study is to compare the respiratory and acute hemodynamic effects of caffeine administered in the first 2 hours versus 12 hours of life in infants \<29 weeks gestation. Our primary hypothesis is that caffeine administered in the first two hours of life can prevent the need for endotracheal intubation in the first 12 hours of life.. These evaluations are critical in determining both the safety and efficacy of early caffeine therapy.

Conditions

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Caffeine

Keywords

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caffeine intubation hemodynamic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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early caffeine

Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 15 minutes within the first 2 hours of life. If the infant is in the early caffeine group, the blinded drug will be IV caffeine citrate 20mg/kg in the first 2 hours and placebo at 12 hours of life.

Group Type ACTIVE_COMPARATOR

Caffeine

Intervention Type DRUG

Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 2 hours of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose.

Routine caffeine

Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 2 hours of life. If the infant is in the routine caffeine group, the blinded drug will be placebo in the DR and IV caffeine citrate 20mg/kg at 12 hours of life.

Group Type PLACEBO_COMPARATOR

Caffeine

Intervention Type DRUG

Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 2 hours of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose.

Interventions

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Caffeine

Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 2 hours of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose.

Intervention Type DRUG

Other Intervention Names

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caffeine citrate IV caffeine

Eligibility Criteria

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Inclusion Criteria

* Any infant delivered at Sharp Mary Birch Hospital between 23 and 28 6/7 weeks; gestation

Exclusion Criteria

* Any infant with a major congenital anomaly including airway anomalies, congenital diaphragmatic hernia, or hydrops
* Any infant with a known or a discovered major cardiac defect other than a patent ductus arterious (PDA), patent foramen ovale (PFO), or small ventricular septal defect (VSD)
* Inability to place a peripheral IV after two attempts. Severe apnea or bradycardia in the first 60 minutes of life requiring emergent endotracheal intubation.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sharp HealthCare

OTHER

Sponsor Role lead

Responsible Party

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Anup Katheria, M.D.

Director of Neonatal Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anup Katheria, MD

Role: PRINCIPAL_INVESTIGATOR

Sharp HealthCare

Locations

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Sharp Memorial Hospital

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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2HRCAFFEINE

Identifier Type: -

Identifier Source: org_study_id