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Study on the predictive value of wave VI of brainstem auditory evoked potential in neonatal sedation

Study on the predictive value of waveVI of brainstem auditory evoked potential in neonatal sedation

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068407
Enrollment
Unknown
Registered
2023-02-17
Start date
2023-02-20
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

neonatal sedation

Interventions

Drug Group :Oral chloral hydrate 50mg/kg
Control Group:no

Sponsors

Wenling Matemal and Child Health Care Hospital, Zhejiang, China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 1 Years

Inclusion criteria

Inclusion criteria: 1. The birth weight > 2000g,singleton, the gestational age >35 weeks; 2. TSB within 7 days < the 95% percentile of Bhutani's hourly bilirubin nomogram, BAEP examination is performed on the 7th to 14th day of birth.

Exclusion criteria

Exclusion criteria: 1. Twins or multiple; 2. Suffocation rescuers (Apgar score 1 min 0~4 points or 5 min 0~6 points); 3. Neonatal genetic metabolic disease or glucose-6-phosphate dehydrogenase deficiency; 4. Hypoxemia or mechanical ventilation for more than 5 days; 5. Have a family history of permanent hearing impairment and intrauterine infection caused by cytomegalovirus, rubella virus, herpes virus, syphilis or toxoplasma gondii; 6. Craniofacial deformities, including auricle and auditory canal deformities; 7. The mother used ototoxic drugs during pregnancy; 8. Suffering from bacterial meningitis; 9. Syndromes or Genetic diseases related to hearing impairment; 10. TSB>342µmol/L within 7 days of birth; 11. The clinical data are unreliable or incomplete, and the parents refuse to treat, automatically discharge, and die; 12. Children with contraindications of chloral hydrate.

Design outcomes

Primary

MeasureTime frame
Wave VI of BAEP;latency of VI wave;

Countries

China

Contacts

Public ContactZhimin Sheng

Wenling Matemal and Child Health Care Hospital, Zhejiang, China

108422045@qq.com+86 13606686500

Outcome results

None listed

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