Clinical trial NCT06026163: Caffeine as an Adjuvant Therapy for Late Preterm Infants With Respiratory Distress
Official title: Caffeine for Late Preterm Infants: A Double Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Prematurity
Respiratory Disease
Ventilator Lung; Newborn
Keywords: caffeine
preterm
newborn
respiratory support
Lead sponsor: Ministry of Health, Saudi Arabia
Sponsor class: OTHER_GOV
First posted: 2023-09-06
Enrollment: 134
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Duration of respiratory support
timeFrame: 28 days
Secondary outcomes:
measure: Episodes of apnea
timeFrame: 28 gays
measure: Failure of extubation
timeFrame: 28 days
measure: Duration of caffeine
timeFrame: 28 days
measure: Length of hospital stay
timeFrame: 28 days
measure: Time to full enteral and oral feeding
timeFrame: 28 days
measure: Adverse effects of caffeine use
timeFrame: 28 days
measure: Caffeine withhold
timeFrame: 28 days
measure: Weight gain per day
timeFrame: 28 days
measure: Mortality
timeFrame: 28 days
measure: Readmission rate
timeFrame: 28 days
measure: Days of apnea
timeFrame: 28 days
Other outcomes:
Locations:
city: Medina
country: Saudi Arabia
facility: King Salman Bin Abdulaziz Medical City
city: Medina
country: Saudi Arabia
facility: King Salman Bin Abdulaziz Medical City
Study officials:
affiliation: Neonatology Consultant
name: Nehad Nasef
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.