Caffeine as Respiratory Stimulant in Preterm Infants

NCT04144712 | Unknown Phase 1 FDA Drug

• 1 other identifier: FWA 000017685
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

comparison between rate of occurance of apnea of prematurity AOP when using high and low dose caffeine

Conditions

Apnea of Prematurity

Outcome Measures

Primary Outcomes (1)

• High Versus Low Dose Caffeine as Respiratory Stimulant in Preterm Infants

  assess occurrence of apnea of prematurity between infants receiving high and low dose caffeine

  baseline

Study Arms (2)

High Dose arm

EXPERIMENTAL

subjects will receive the high dose of the drug

Drug: Caffeine Citrate

low dose arm

ACTIVE COMPARATOR

subject will receive low dose of the drug

Drug: Caffeine Citrate

Interventions

Caffeine Citrate DRUG

study rate of occurrence of Apnea of Prematurity between the 2 groups

High Dose arm; low dose arm

Eligibility Criteria

• Age: Up to 10 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants with a gestational age \<32 weeks in room air or CPAP (prophylactic).
• Preterm infants with gestational age 32-34 weeks who exhibited apnea of prematurity within the first 10 days of life in room air or CPAP

You may not qualify if:

• Major congenital malformations.
• Chromosomal anomalies.
• Preterm infants on mechanical ventilation.
• Preterm infants on NIPPV.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Medicine ain shams University

Cairo, 11591, Egypt

RECRUITING

Related Publications (5)

• Faramarzi F, Shiran M, Rafati M, Farhadi R, Salehifar E, Nakhshab M. The efficacy and safety of two different doses of caffeine in respiratory function of preterm infants. Caspian J Intern Med. 2018 Winter;9(1):46-53. doi: 10.22088/cjim.9.1.46.

  PMID: 29387319 BACKGROUND

• Schmidt B, Roberts RS, Davis P, Doyle LW, Barrington KJ, Ohlsson A, Solimano A, Tin W; Caffeine for Apnea of Prematurity Trial Group. Caffeine therapy for apnea of prematurity. N Engl J Med. 2006 May 18;354(20):2112-21. doi: 10.1056/NEJMoa054065.

  PMID: 16707748 BACKGROUND

• Kraaijenga JV, Hutten GJ, de Jongh FH, van Kaam AH. The Effect of Caffeine on Diaphragmatic Activity and Tidal Volume in Preterm Infants. J Pediatr. 2015 Jul;167(1):70-5. doi: 10.1016/j.jpeds.2015.04.040. Epub 2015 May 15.

  PMID: 25982138 BACKGROUND

• Mohammed S, Nour I, Shabaan AE, Shouman B, Abdel-Hady H, Nasef N. High versus low-dose caffeine for apnea of prematurity: a randomized controlled trial. Eur J Pediatr. 2015 Jul;174(7):949-56. doi: 10.1007/s00431-015-2494-8. Epub 2015 Feb 3.

  PMID: 25644724 BACKGROUND

• Zhao Y, Tian X, Liu G. [Clinical effectiveness of different doses of caffeine for primary apnea in preterm infants]. Zhonghua Er Ke Za Zhi. 2016 Jan;54(1):33-6. doi: 10.3760/cma.j.issn.0578-1310.2016.01.008. Chinese.

  PMID: 26791921 BACKGROUND

MeSH Terms

Conditions

Apnea

Interventions

caffeine citrate

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yasmin A Farid, MD

  Pediatric Department Faculty of Medicine Ain shams University

  STUDY DIRECTOR

• Ola G Badr El-Deen, MD

  Pediatric Department Faculty of Medicine Ain shams University

  STUDY CHAIR

Central Study Contacts

Eslam M Mazrou, MBBCH

CONTACT

20201009429972; eslammazrou@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Pediatric Resident

Model Details: The current study will be carried on preterm infants admitted to the Neonatal Intensive Care Unit (NICU), Ain Shams University 80 Patients divided into two groups each group will contain 40 subjects Group sample sizes of 40 and 40 achieve 83% power to detect a difference of -7.0 regarding frequency of apnea attacks between the null hypothesis that both group means are 9.0 and the alternative hypothesis that the mean of group 2 is 16.0 with known group standard deviations of 3.7 and 5.2 and with a significance level (alpha) of 0.05000 using a two-sided Mann-Whitney test assuming that the actual distribution is uniform

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: October 30, 2019
• Study Start: April 1, 2019
• Primary Completion: October 1, 2020
• Study Completion: November 1, 2020
• Last Updated: February 7, 2020

Record last verified: 2019-10

Locations

EG (1)