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Prevention and treatment effect of traditional Chinese medical five-tone therapy combined with caffeine citrate on apnea of prematurity

Prevention and treatment effect of traditional Chinese medical five-tone therapy combined with caffeine citrate on apnea of prematurity

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067524
Enrollment
Unknown
Registered
2023-01-10
Start date
2023-02-01
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

apnea

Interventions

control group:Caffeine citrate drug treatment
Experimental group ?:Treatment with five-tone therapy combined with caffeine citrate (the first dose of caffeine citrate is 20mg/kg, and 5mg/kg is changed after 24 hours, once a day)
Experimental group ?:Treatment with five-tone therapy combined with caffeine citrate (the first dose of caffeine citrate is 20mg/kg, and 10mg/kg is changed after 24 hours, once a day)

Sponsors

Jiangxi Maternal and Child Health Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Giving birth in Jiangxi Provincial Maternal and Child Health Care Hospital; (2) need non-invasive respiratory support; (3) The baby is born between 28-32 weeks for gestational age and has a birth weight of less than 1500g

Exclusion criteria

Exclusion criteria: (1) severe asphyxiation; (2) need invasive mechanical ventilation support; (3) Accompanied by severe congenital malformations, especially ear malformations, hereditary metabolic diseases, chromosomal or genetic abnormalities; (4) severe intracranial hemorrhage or neuromuscular disease; (5) Hearing dysfunction (otoacoustic emission does not pass through both ears); (6) TORCH infection

Design outcomes

Primary

MeasureTime frame
the incidence of apnea at 34 weeks' gestation;Number of apnea occurrences per day;Time for apnea to disappear;Timefor noninvasive assisted ventilation;Time of treatment with oxygen;Time of treatment with caffeine citrate;duration of hospitalization;

Secondary

MeasureTime frame
incidence of tachycardia;incidence of feeding intolerance;incidence of necrotizing enterocolitis;incidence of retinopathy of prematurity;Incidence of bronchopulmonary dysplasia;Incidence of intraventricular hemorrhage;Incidence of white matter malacia;

Countries

China

Contacts

Public ContactQin Luo

Jiangxi Maternal and Child Health Hospital

luoqin_jxmchh@163.com13767197860

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026