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Safety and effectiveness of an oral novel formulation of midazolam for sedation in neonatal MRI: a prospective, single-center, randomized controlled trial

Safety and effectiveness of an oral novel formulation of midazolam for sedation in neonatal MRI: a prospective, single-center, randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069996
Enrollment
Unknown
Registered
2023-03-30
Start date
2023-04-01
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

neonatal MRI exmanation sedation

Interventions

Midazolam oral solution group:Midazolam oral solution is administered orally
Chloral hydrate group:Chloral hydrate isadministered orally

Sponsors

Chengdu Women’s & Children’s Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Neonates with gestational age >37 weeks, weight >2500g, stable vital signs and no need for oxygen were admitted to the neonatology Department of Chengdu Women and Children's Central Hospital from March 2023 to March 2024; (2) Head MRI examination was required due to the condition. (3) Voluntary participation and signing of informed consent.

Exclusion criteria

Exclusion criteria: (1) serious heart and lung diseases; (2) Children with endotracheal intubation or failure to deoxygenate; (3) Airway obstruction, craniofacial deformity, and risk of difficult tracheal intubation; (4) severe dehydration or malnutrition, severe liver insufficiency; (5) combined with vomiting and gastroesophageal reflux; (6) Allergic to chloral hydrate and midazolam.

Design outcomes

Primary

MeasureTime frame
successful sedation;

Secondary

MeasureTime frame
Sedation onset time (UMSS score = 2);Adverse reactions;Sedation score;Vital signs;Number of successful cases and success rate of the first sedation remedy;Respiratory complications;

Countries

China

Contacts

Public ContactXu Li

Chengdu Women’s & Children’s Central Hospital

414993490@qq.com+86 135 4789 6801

Outcome results

None listed

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