Menu
Recruiting NCT06026163

Caffeine as an Adjuvant Therapy for Late Preterm Infants With Respiratory Distress

Phase II / Phase III Interventional Prematurity Respiratory Disease Ventilator Lung; Newborn

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Caffeine citrate, Placebo.
Who it may be relevant to
Registry conditions: Prematurity, Respiratory Disease, Ventilator Lung; Newborn. Basic parameters: 1 Day — 3 Days · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Saudi Arabia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Caffeine for Late Preterm Infants: A Double Blind Randomized Controlled Trial

Overview

Use of caffeine citrate in late-preterm infants with respiratory distress is questionable. Oliphant and colleagues found in a recently published study that caffeine therapy use in late-preterm infants at a loading dose of 20 and 40 mg/kg and maintenance dose of 10 and 20 mg/kg/day reduces the incidence of intermittent hypoxia events by 61 and 67% respectively. The investigators hypothesized that caffeine will improve respiratory drive, prevent apnea, shorten the hospital stay and improve arousal state in late preterm infants. The investigators aim to study the effect of caffeine citrate on late preterm babies as regard duration of respiratory support, duration of hospital stay, respiratory morbidity, incidence and frequency of apnea.

Detailed description

late preterm infants will be randomized in a blinded manner to receive either caffeine in loading dose 20 mg/kg (equivalent for 10 mg/kg caffeine base) and maintenance dose 10 mg/kg/day (equivalent for 5 mg/kg caffeine base) in Caffeine treatment group, or equivalent volume of saline in the placebo group. Caffeine will be continued until infants get off all forms of respiratory support.

Preparation of caffeine and placebo will be performed by a designated pharmacist who is not part of the study. Parents and investigators will be remained blinded to the administered medications throughout the study period.

Interventions

  • Drug Caffeine citrate
    Caffeine citrate in loading dose 20 mg/kg (equivalent for 10 mg/kg caffeine base) and maintenance dose 10 mg/kg/day (equivalent for 5 mg/kg caffeine base)
  • Other Placebo
    Equivalent volume of saline

Primary outcome measures

  • Duration of respiratory support [Time frame: 28 days]
Secondary outcome measures (11)
  • Episodes of apnea [Time frame: 28 gays]
  • Failure of extubation [Time frame: 28 days]
  • Duration of caffeine [Time frame: 28 days]
  • Length of hospital stay [Time frame: 28 days]
  • Time to full enteral and oral feeding [Time frame: 28 days]
  • Adverse effects of caffeine use [Time frame: 28 days]
  • Caffeine withhold [Time frame: 28 days]
  • Weight gain per day [Time frame: 28 days]
  • Mortality [Time frame: 28 days]
  • Readmission rate [Time frame: 28 days]
  • Days of apnea [Time frame: 28 days]

Eligibility criteria

Inclusion criteria

  • Newborn infants at gestational age 34 0/7 through 36 6/7
  • Presented with respiratory distress
  • Require respiratory support in the form of any of the following :

A) Invasive mechanical ventilation, B) Non-invasive positive pressure ventilation, C) Nasal cannula with FIO2 requirement over 50% to keep pre-ductal saturation between 90-95%.

Exclusion criteria

1 - Late preterm admitted for non-respiratory etiologies 2- Late preterm infants requiring nasal cannula on less than 50% FIO2 by 4 hours of age as they are less likely to require respiratory support for a long time.

3- Newborn infants with congenital malformations and chromosomal anomalies. 4- Infants with echocardiographic evidence of PPHN requiring medical intervention.

5- Late preterm with history of maternal substance abuse

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Saudi Arabia · 2 centers
  • King Salman Bin Abdulaziz Medical City — Madinah
  • King Salman Bin Abdulaziz Medical City — Madinah

Publications

  • Davis PG, Schmidt B, Roberts RS, Doyle LW, Asztalos E, Haslam R, Sinha S, Tin W; Caffeine for Apnea of Prematurity Trial Group. Caffeine for Apnea of Prematurity trial: benefits may vary in subgroups. J Pediatr. 2010 Mar;156(3):382-7. doi: 10.1016/j.jpeds.2009.09.069. Epub 2009 Nov 18. PMID 19926098
  • Eichenwald EC; Committee on Fetus and Newborn, American Academy of Pediatrics. Apnea of Prematurity. Pediatrics. 2016 Jan;137(1). doi: 10.1542/peds.2015-3757. Epub 2015 Dec 1. PMID 26628729

Identifiers

NCT: NCT06026163 · H-09-M-11

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗