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A Randomized Controlled Trial for Feeding Intolerance & NEC incidence and rStO2 Monitoring Techniques in Neonatal Brain and Abdomen

Monitoring of neonatal brain and abdominal tissue oxygen saturation by neoinfrared spectroscopy and its randomized controlled trial for neonatal feeding intolerance and necrotizing enterocolitis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900021777
Enrollment
Unknown
Registered
2019-03-09
Start date
2019-05-01
Completion date
Unknown
Last updated
2019-03-11

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

Conditions

Feeding Intolerance & NEC

Interventions

Experimental group:Clinical intervention based on rSCO2 results
control group:Diagnosis and treatment based on clinical symptoms

Sponsors

the Fifth Medical Center of the PLA General Hospital, NICU
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Newborns patients within 24 hours after birth; 2. Their parents have signed the informed consent; 3. Their parents agree to the active treatment and the related life support; 4. Newborns who can perform continuous cerebral oxygen and abdominal oxygen and monitoring; 5. Vital signs stable (VSS).

Exclusion criteria

Exclusion criteria: 1. Newborns with genetic metabolic diseases or birth defects (such as cardiovascular system, digestive system or nervous system dysplasia); 2. Patients who have any with trauma, malformation or other abnormalities that may affect tissue oxygen saturation and data acquisition at the sensor placement site; 3. Patients who have a history of suffocation and hypoxia; 4. Patients who have infection within 72 hours after birth; 5. Patients who can meet the admission criteria but whose admission time is more than 24 hours after birth.

Design outcomes

Primary

MeasureTime frame
NEC incidence rate;LOS incidence rate;

Countries

China

Contacts

Public ContactZhang Xuefeng

the Fifth Medical Center of the PLA General Hospital

doctor1966@sina.com+86 13511058765

Outcome results

None listed

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