Apnea of Prematurity Results in Respiratory Distress and Cyanosis. Caffeine Citrate Can Treat It.

NCT06905496 | Active Not Recruiting Phase 1

• 2 other identifiers: HDLDCC2025Nishtar Hospital Multan
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

High-dose caffeine citrate is more effective than low-dose caffeine citrate in the treatment of apnea of prematurity (AOP). The high-dose group showed fewer apnea episodes, higher extubation success rate, lower extubation failure rate and shorter duration of oxygen therapy

Conditions

Apnea of Prematurity

Keywords

caffeine citrate; apnea; prematurity

Outcome Measures

Primary Outcomes (1)

• Enhanced Respiratory Stimulation, Effect of Caffeine Citrate on the stimulation of respiratory system of premature individuals

  High dose vs low dose caffeine citrate effect in apnea of prematurity. The concentration of caffeine citrate as 40mg high dose and 20mg low dose will be considered. The measurement tool will be percentage of patients recovering from this high vs low concentration. The effect of caffeine citrate doses on respiratory stimulation of premature babies will be studied. High doses are expected to improve respiratory distress associated with prematurity. Patients will be clinically assessed after the given doses of caffeine citrate and any improvement, if present, will be noted.

  2-3 days after starting the intervention

Study Arms (2)

High-Dose Group

EXPERIMENTAL

High dose group will be administered a loading dose of oral caffeine citrate at 40 mg/kg/day followed by a maintenance dose of 20 mg/kg/day for 7 days

Drug: High-Dose; Drug: Low Dose

Low-Dose Group

EXPERIMENTAL

Low-dose group will receive a loading dose of 20 mg/kg/day and a maintenance dose of 10 mg/kg/day for 7 days

Drug: High-Dose; Drug: Low Dose

Interventions

High-Dose DRUG

Caffeine

Also known as: Caffeine Citrate 40mg/kg/day

High-Dose Group; Low-Dose Group

Low Dose DRUG

Caffeine citrate is a combination of caffeine and citric acid, commonly used as a central nervous system stimulant. It is primarily used to treat apnea of prematurity in neonates.

High-Dose Group; Low-Dose Group

Eligibility Criteria

• Age: 1 Day - 10 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients with a gestational age of ≥32 and \<37 weeks at birth on LMP.
• Diagnosis of apnea of prematurity (AOP) established as per operational definition within the first 10 days of life.
• Either male or female patients

You may not qualify if:

• Patients diagnosed with Hydrops fetalis (evaluated through medical record).
• Patients presenting with major congenital or chromosomal anomalies such as anencephaly, spina bifida, congenital heart defects (e.g., tetralogy of Fallot, transposition of the great arteries), or chromosomal disorders (e.g., trisomy 18, Turner syndrome).
• Presence of a confirmed sepsis through blood culture.
• Presence of a significant underlying neurological disorder evaluated by history and medical records that could contribute to apnea (e.g., intraventricular hemorrhage with posthemorrhagic hydrocephalus, hypoxic-ischemic encephalopathy)
• Patients who have been previously treated with caffeine or other methylxanthines for apnea.

Sponsors & Collaborators

• Nishtar Medical University: lead

Study Sites (1)

Nishtar Medical Hospital, Multan

Multan, Punjab Province, 60000, Pakistan

Location

MeSH Terms

Conditions

Apnea; Premature Birth

Interventions

caffeine citrate; Contraceptives, Oral

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Study Officials

• Fatima Zahra, FCPS

  Nishtar Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Graduate Resident

Study Record Dates

• First Submitted: March 1, 2025
• First Posted: April 1, 2025
• Study Start: June 3, 2024
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)