Effect of Early Use of Caffeine Citrate in Preterm Neonates

NCT04001712 | Completed Phase 3

• 1 other identifier: early caffeine in preterm
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This work is designed to study the effect of the early use of caffeine citrate in preterm neonates who need respiratory support on morbidity and short term neonatal outcome.

Conditions

Preterm Birth

Keywords

early caffeine preterm

Outcome Measures

Primary Outcomes (1)

• duration of respiratory support in preterm neonates receiving early caffeine citrate

  preterm neonates of gestational age 33 weeks or less needing any respiratory support (CPAP , mechanical ventilation....)were given caffeine citrate at the start of the support. duration of the support was compared to the duration of respiratory support in the other arm that includes preterm neonates of gestational age 33 weeks or less needing any respiratory support and receiving caffeine citrate 6 hours before weaning only.

  throughout admission in neonatal intensive care unit average of 4 weeks (from the beginning of hospital admission till discharge) average of

Study Arms (2)

early caffeine citrate group

EXPERIMENTAL

preterm neonates who require respiratory support either nasal canula, continuous positive airway pressure (CPAP) or mechanical ventilation.were given caffeine citrate upon start of the respiratory support Caffeine citrate was given at a loading dose of 10 mg/kg and with a daily maintenance dose of 5 mg/kg until the patient was off respiratory support

Drug: Caffeine Citrate

late caffeine citrate group

ACTIVE COMPARATOR

preterm neonates who require respiratory support either nasal canula, continuous positive airway pressure (CPAP) or mechanical ventilation.were given caffeine citrate 6 hours before weaning of respiratory support

Drug: Caffeine Citrate

Interventions

Caffeine Citrate DRUG

caffeine citrate is given early to preterm neonates in need of respiratory support

early caffeine citrate group; late caffeine citrate group

Eligibility Criteria

• Age: Up to 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm neonates ≤ 33 weeks gestational age.
• Preterm neonates who need respiratory support (either nasal canula, continuous positive airway pressure (CPAP) or mechanical ventilation).

You may not qualify if:

• Neonate\>33 wks gestational age.
• Neonates on room air.
• Neonates with major congenital or cardiac anomalies

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Cairo Governorate, 1825, Egypt

Location

Related Publications (3)

• Lista G, Fabbri L, Polackova R, Kiechl-Kohlendorfer U, Papagaroufalis K, Saenz P, Ferrari F, Lasagna G, Carnielli VP; Peyona(R) PASS Group. The Real-World Routine Use of Caffeine Citrate in Preterm Infants: A European Postauthorization Safety Study. Neonatology. 2016;109(3):221-7. doi: 10.1159/000442813. Epub 2016 Jan 28.

  PMID: 26820884 BACKGROUND

• Lodha A, Seshia M, McMillan DD, Barrington K, Yang J, Lee SK, Shah PS; Canadian Neonatal Network. Association of early caffeine administration and neonatal outcomes in very preterm neonates. JAMA Pediatr. 2015 Jan;169(1):33-8. doi: 10.1001/jamapediatrics.2014.2223.

  PMID: 25402629 BACKGROUND

• Rivera-Oliver M, Diaz-Rios M. Using caffeine and other adenosine receptor antagonists and agonists as therapeutic tools against neurodegenerative diseases: a review. Life Sci. 2014 Apr 17;101(1-2):1-9. doi: 10.1016/j.lfs.2014.01.083. Epub 2014 Feb 13.

  PMID: 24530739 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Interventions

caffeine citrate

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Bassem El Sayed

  Ain Shams University

  STUDY CHAIR

• Sameh Amer

  Medical Military Academy

  STUDY CHAIR

• Hisham Awad

  Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: randomized controlled phase 3 clinical trial

Study Record Dates

• First Submitted: June 22, 2019
• First Posted: June 28, 2019
• Study Start: April 5, 2019
• Primary Completion: May 5, 2019
• Study Completion: June 10, 2019
• Last Updated: July 2, 2019

Record last verified: 2019-06

Locations

EG (1)