Caffeine as an Adjuvant Therapy for Late Preterm Infants With Respiratory Distress
CAT/LPT
Caffeine for Late Preterm Infants: A Double Blind Randomized Controlled Trial
1 other identifier
interventional
134
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2023
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2023
CompletedFirst Posted
Study publicly available on registry
September 6, 2023
CompletedStudy Start
First participant enrolled
October 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
June 27, 2025
June 1, 2025
4.1 years
August 27, 2023
June 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Duration of respiratory support
cumulative duration of mechanical ventilation, non-invasive positive pressure ventilation and nasal cannula therapy (days)
28 days
Secondary Outcomes (11)
Episodes of apnea
28 gays
Failure of extubation
28 days
Duration of caffeine
28 days
Length of hospital stay
28 days
Time to full enteral and oral feeding
28 days
- +6 more secondary outcomes
Study Arms (2)
Caffeine citrate group
EXPERIMENTALInfants 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).
Control group
PLACEBO COMPARATORInfants received equivalent volume of saline.
Interventions
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)
Eligibility Criteria
You may qualify if:
- 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%.
You may not qualify if:
- 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.
- Newborn infants with congenital malformations and chromosomal anomalies. 4- Infants with echocardiographic evidence of PPHN requiring medical intervention.
- Late preterm with history of maternal substance abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
King Salman Bin Abdulaziz Medical City
Madinah, Medina Region, 42319, Saudi Arabia
King Salman Bin Abdulaziz Medical City
Madinah, Saudi Arabia
Related Publications (2)
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: 19926098BACKGROUNDEichenwald 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: 26628729BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nehad Nasef
Neonatology Consultant
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- NICU Director
Study Record Dates
First Submitted
August 27, 2023
First Posted
September 6, 2023
Study Start
October 12, 2023
Primary Completion (Estimated)
October 30, 2027
Study Completion (Estimated)
January 1, 2028
Last Updated
June 27, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data requests can be submitted starting 3 months after article publication and the data will be made accessible for up to 12 months. Extensions will be considered on a case-by-case basis."
- Access Criteria
- Access to raw data (no protected health information) can be requested by qualified researchers for scientific purposes, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA)
Data obtained through this study may be provided to qualified researchers for research and scientific purposes (i.e conduction of meta-analysis or systematic review). Data or samples shared will be coded, with no protected health information included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.