Back to resultsCaffeine as an Adjuvant Therapy for Late Preterm Infants With Respiratory Distress (CAT/LPT)
Primary Purpose
Prematurity, Respiratory Disease, Ventilator Lung; Newborn
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Caffeine citrate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Prematurity focused on measuring caffeine, preterm, newborn, respiratory support
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Caffeine citrate group
Control group
Arm Description
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).
Infants received equivalent volume of saline.
Outcomes
Primary Outcome Measures
Duration of respiratory support
cumulative duration of mechanical ventilation, non-invasive positive pressure ventilation and nasal cannula therapy (days)
Secondary Outcome Measures
Episodes of apnea
the cessation of breathing for more than 20 seconds or cessation of breathing for accompanied by bradycardia or desaturation
Failure of extubation
need of re-intubation within 72 h of extubation from mechanical ventilation
Duration of caffeine
Days of caffeine treatment
Length of hospital stay
days of hospital admission
Time to full enteral and oral feeding
days to reach full enteral feeds
Adverse effects of caffeine use
Tachycardia, irritability, feeding intolerance, hypertension
Caffeine withhold
Caffeine withhold for suspected side effects
Weight gain per day
Weight gain per day (gram)
Mortality
Death before hospital discharge
Readmission rate
Readmission to the hospital with respiratory related symptoms within 48 hours of hospital discharge
Days of apnea
Full Information
NCT ID
NCT06026163
First Posted
August 27, 2023
Last Updated
September 3, 2023
Sponsor
Ministry of Health, Saudi Arabia
1. Study Identification
Unique Protocol Identification Number
NCT06026163
Brief Title
Caffeine as an Adjuvant Therapy for Late Preterm Infants With Respiratory Distress
Acronym
CAT/LPT
Official Title
Caffeine for Late Preterm Infants: A Double Blind Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Health, Saudi Arabia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity, Respiratory Disease, Ventilator Lung; Newborn
Keywords
caffeine, preterm, newborn, respiratory support
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
134 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Caffeine citrate group
Arm Type
Experimental
Arm Description
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).
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Infants received equivalent volume of saline.
Intervention Type
Drug
Intervention Name(s)
Caffeine citrate
Other Intervention Name(s)
Intervention group
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline
Intervention Description
Equivalent volume of saline
Primary Outcome Measure Information:
Title
Duration of respiratory support
Description
cumulative duration of mechanical ventilation, non-invasive positive pressure ventilation and nasal cannula therapy (days)
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Episodes of apnea
Description
the cessation of breathing for more than 20 seconds or cessation of breathing for accompanied by bradycardia or desaturation
Time Frame
28 gays
Title
Failure of extubation
Description
need of re-intubation within 72 h of extubation from mechanical ventilation
Time Frame
28 days
Title
Duration of caffeine
Description
Days of caffeine treatment
Time Frame
28 days
Title
Length of hospital stay
Description
days of hospital admission
Time Frame
28 days
Title
Time to full enteral and oral feeding
Description
days to reach full enteral feeds
Time Frame
28 days
Title
Adverse effects of caffeine use
Description
Tachycardia, irritability, feeding intolerance, hypertension
Time Frame
28 days
Title
Caffeine withhold
Description
Caffeine withhold for suspected side effects
Time Frame
28 days
Title
Weight gain per day
Description
Weight gain per day (gram)
Time Frame
28 days
Title
Mortality
Description
Death before hospital discharge
Time Frame
28 days
Title
Readmission rate
Description
Readmission to the hospital with respiratory related symptoms within 48 hours of hospital discharge
Time Frame
28 days
Title
Days of apnea
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ohoud Almoualled, Dr
Phone
+966500550679
Email
o.doc2or@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nehad Nasef
Organizational Affiliation
Neonatology Consultant
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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."
IPD Sharing 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)
Citations:
PubMed Identifier
19926098
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.
Results Reference
background
PubMed Identifier
26628729
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.
Results Reference
background
PubMed Identifier
36038256
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-2022-324010. Epub 2022 Aug 29.
Results Reference
result
Learn more about this trial
Caffeine as an Adjuvant Therapy for Late Preterm Infants With Respiratory Distress
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