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

NCT ID: NCT06026163

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-12
• Study Completion Date: 2028-01-01

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.

Conditions

Prematurity; Respiratory Disease; Ventilator Lung; Newborn

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: EXPERIMENTAL

Caffeine citrate

Intervention Type: DRUG

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

Infants received equivalent volume of saline.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Equivalent volume of saline

Interventions

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)

Intervention Type: DRUG

Placebo

Equivalent volume of saline

Intervention Type: OTHER

Other Intervention Names

Intervention group; Saline

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 3 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Saudi Arabia

OTHER_GOV

Sponsor Role: lead

Responsible Party

Fatema Sulaiman Alhazmi

NICU Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nehad Nasef

Role: PRINCIPAL_INVESTIGATOR

Neonatology Consultant

Locations

King Salman Bin Abdulaziz Medical City

Madinah, Medina Region, Saudi Arabia

Site Status: RECRUITING

King Salman Bin Abdulaziz Medical City

Madinah, , Saudi Arabia

Site Status: RECRUITING

Countries

Saudi Arabia

Central Contacts

Ohoud Almoualled, Dr

Role: CONTACT

o.doc2or@gmail.com

+966500550679

Facility Contacts

Yasmeen T Aljhani

Role: primary

med-ksamc-irb@moh.gov.sa

+966148499629

Yasmeen T Aljhani

Role: primary

med-ksamc-irb@moh.gov.sa

+966148499629

References

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.

Reference Type: BACKGROUND

PMID: 19926098 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26628729 (View on PubMed)

Other Identifiers

H-09-M-11

Identifier Type: -

Identifier Source: org_study_id