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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06026163
Other study ID # H-09-M-11
Secondary ID
Status Not yet recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date October 2023
Est. completion date March 2025

Study information

Verified date September 2023
Source Ministry of Health, Saudi Arabia
Contact Ohoud Almoualled, Dr
Phone +966500550679
Email o.doc2or@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 134
Est. completion date March 2025
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 1 Day to 3 Days
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ministry of Health, Saudi Arabia

References & Publications (3)

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. — View 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. — View Citation

Oliphant EA, McKinlay CJ, McNamara D, Cavadino A, Alsweiler JM. Caffeine to prevent intermittent hypoxaemia in late preterm infants: randomised controlled dosage trial. Arch Dis Child Fetal Neonatal Ed. 2023 Mar;108(2):106-113. doi: 10.1136/archdischild-2 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Duration of respiratory support cumulative duration of mechanical ventilation, non-invasive positive pressure ventilation and nasal cannula therapy (days) 28 days
Secondary Episodes of apnea the cessation of breathing for more than 20 seconds or cessation of breathing for accompanied by bradycardia or desaturation 28 gays
Secondary Failure of extubation need of re-intubation within 72 h of extubation from mechanical ventilation 28 days
Secondary Duration of caffeine Days of caffeine treatment 28 days
Secondary Length of hospital stay days of hospital admission 28 days
Secondary Time to full enteral and oral feeding days to reach full enteral feeds 28 days
Secondary Adverse effects of caffeine use Tachycardia, irritability, feeding intolerance, hypertension 28 days
Secondary Caffeine withhold Caffeine withhold for suspected side effects 28 days
Secondary Weight gain per day Weight gain per day (gram) 28 days
Secondary Mortality Death before hospital discharge 28 days
Secondary Readmission rate Readmission to the hospital with respiratory related symptoms within 48 hours of hospital discharge 28 days
Secondary Days of apnea 28 days
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