Early Versus Routine Caffeine Administration in Extremely Preterm Neonates

NCT01783561 | Completed Phase 4 Results DMC

• 1 other identifier: 2HRCAFFEINE
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Caffeine

Keywords

caffeine; intubation; hemodynamic

Outcome Measures

Primary Outcomes (1)

• Intubation

  The primary aim of our study is to compare the respiratory effects of caffeine administered in the first 2 hours versus at 12 hours of life in infants \<29 weeks' gestation. Our primary hypothesis is that early caffeine administered (at \< 2 hours of life) can prevent the need for endotracheal intubation in the first 12 hours of life.

  First 12 hours of life

Secondary Outcomes (2)

• Subjects Requiring Inotropes in the First 24 Hours

  first 24 hours of life

• Systemic Blood Flow

  first 24 hours

Study Arms (2)

early caffeine

ACTIVE COMPARATOR

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.

Drug: Caffeine

Routine caffeine

PLACEBO COMPARATOR

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.

Drug: Caffeine

Interventions

Caffeine 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.

Also known as: caffeine citrate, IV caffeine

Routine caffeine; early caffeine

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sharp HealthCare: lead

Study Sites (1)

Sharp Memorial Hospital

San Diego, California, 92103, United States

Location

MeSH Terms

Interventions

Caffeine; caffeine citrate

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Anup Katheria, M.D.
• Organization: Neonatal Research Institute, Sharp Mary Birch Hospital for Women and Newborns

anup.katheria@sharp.com

858-939-4170

Study Officials

• Anup Katheria, MD

  Sharp HealthCare

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Neonatal Research

Study Record Dates

• First Submitted: January 31, 2013
• First Posted: February 5, 2013
• Study Start: October 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: December 11, 2018
• Results First Posted: August 1, 2017

Record last verified: 2018-11

Locations

US (1)