CAT/LPT: Caffeine as an Adjuvant Therapy for Late Preterm Infants With Respiratory Distress

Sponsor

Ministry of Health, Saudi Arabia (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06026163

Collaborator

(none)

134

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prematurity Respiratory Disease Ventilator Lung; Newborn	Drug: Caffeine citrate Other: Placebo	Phase 2/Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

134 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Caffeine citrate group Infants receive either 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).	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 Names: Intervention group
Placebo Comparator: Control group Infants received equivalent volume of saline.	Other: Placebo Equivalent volume of saline Other Names: Saline

Arm

Intervention/Treatment

Experimental: Caffeine citrate group

Infants receive either 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).

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 Names:

Intervention group

Placebo Comparator: Control group

Infants received equivalent volume of saline.

Other: Placebo

Equivalent volume of saline

Other Names:

Saline

Outcome Measures

Primary Outcome Measures

Duration of respiratory support [28 days]
cumulative duration of mechanical ventilation, non-invasive positive pressure ventilation and nasal cannula therapy (days)

Secondary Outcome Measures

Episodes of apnea [28 gays]
the cessation of breathing for more than 20 seconds or cessation of breathing for accompanied by bradycardia or desaturation
Failure of extubation [28 days]
need of re-intubation within 72 h of extubation from mechanical ventilation
Duration of caffeine [28 days]
Days of caffeine treatment
Length of hospital stay [28 days]
days of hospital admission
Time to full enteral and oral feeding [28 days]
days to reach full enteral feeds
Adverse effects of caffeine use [28 days]
Tachycardia, irritability, feeding intolerance, hypertension
Caffeine withhold [28 days]
Caffeine withhold for suspected side effects
Weight gain per day [28 days]
Weight gain per day (gram)
Mortality [28 days]
Death before hospital discharge
Readmission rate [28 days]
Readmission to the hospital with respiratory related symptoms within 48 hours of hospital discharge
Days of apnea [28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 3 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 :

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