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

Prematurity Clinical Trial

— CAT/LPT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06026163
• Other study ID #: H-09-M-11
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Prematurity
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases
• Ventilator Lung; Newborn

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