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A study on the relationship between intestinal flora and cognitive dysfunction in hypoxic-ischemic brain damage

A study on the relationship between intestinal flora and cognitive dysfunction in hypoxic-ischemic brain damage

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300069101
Enrollment
Unknown
Registered
2023-03-07
Start date
2023-03-31
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

hypoxic-ischemic brain damage

Interventions

Experimental group:ischemic hypoxic brain injury:N/A
control group:normal newborn:N/A

Sponsors

Fujian Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 1 Years

Inclusion criteria

Inclusion criteria: (1) The gestational age of the child is 37 to 40 weeks, and the birth weight is > 2500 g; (2) There is a clear history of abnormal obstetrics that can lead to fetal distress, and severe intrauterine distress (fetal heart rate <100 beats/min for more than 5 minutes; and/or grade III contamination of amniotic fluid), or in A history of obvious asphyxia during childbirth; (3) Severe asphyxia at birth, which refers to Apgar score = 3 points at 1 minute, and = 5 points at 5 minutes, and/or umbilical arterial blood gas pH at birth = 7.00; (4) Neurological symptoms appear shortly after birth and persist for more than 24 hours; (5) The child was born with bruising, paleness, respiratory and circulatory failure, etc.; (6) The children's family members signed the informed consent form after knowing it.

Exclusion criteria

Exclusion criteria: (1) Children with hereditary abnormal glucose and lipid metabolism; (2) Children with congenital heart and lung diseases; (3) Those who have a history of allergy to the drug in this study; (4) Patients with severe liver, kidney and heart dysfunction; (5) Children with congenital malformations, inborn errors of metabolism, congenital viral and bacterial infections; (6) Children with intracranial hemorrhage or other craniocerebral injury; (7) Children with severe heart failure, pulmonary hypertension or severe anemia; (8) Any medical or non-medical condition that the investigator considers inappropriate to participate.

Design outcomes

Primary

MeasureTime frame
Changes of intestinal flora and metabolites;neuron-specific enolase, NSE;S-100B protein,SI00B;brain-derived neurotrophic factor,BDNF;

Secondary

MeasureTime frame
gestational age;birth weight;Birth head circumference;Production mode;Apgar score;Days in hospital;Discharge gestational age;Discharge weight;Days of antibiotic use;C-reactive protein;white blood cell;hemoglobin;platelet;Procalcitonin;

Countries

China

Contacts

Public ContactXiaochun Zheng

Department of Anesthesiology, Fujian Provincial Hospital

zhengxiaochun7766@163.com+86 13705058351

Outcome results

None listed

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