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A Prospective Cohort Study on the Impact of Non-invasive Ventilation on the Shaping of Intestinal Flora and Health Outcomes in Premature Infants

A Prospective Cohort Study on the Impact of Non-invasive Ventilation on the Shaping of Intestinal Flora and Health Outcomes in Premature Infants

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500098799
Enrollment
Unknown
Registered
2025-03-13
Start date
2025-01-04
Completion date
Unknown
Last updated
2025-03-17

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

Conditions

Diseases related to premature infants

Interventions

NIV group:NA
Mechanical ventilation group:NA
Conventional oxygen therapy group (nasal cannula, hood oxygen therapy, incubator oxygen therapy):NA
Non-oxygenation group:NA

Sponsors

Wenling Maternal and Child Health Care Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The guardians of premature infants have sufficient reading comprehension ability and sign the informed consent form. 2. Premature infants with a gestational age of less than 37 weeks. 3. Premature infants who have used antibiotics for less than 5 days.

Exclusion criteria

Exclusion criteria: 1. Severe congenital diseases, including congenital heart disease, digestive tract malformations, and inherited metabolic disorders; 2. Chromosomal abnormalities. 3. Newborns who died without emergency treatment upon admission or died within a few hours despite active rescue and treatment. 4. Newborns who were discharged automatically with a hospitalization period of less than one week. 5. Incomplete clinical data. 6. Families who did not agree to participate and withdrew halfway. 7. Use of probiotics. 8. Use of antibiotics for more than 5 days. 9. Mothers with immune system or severe infectious diseases and a history of using immunosuppressants.

Design outcomes

Primary

MeasureTime frame
Intestinal flora structure;Follow-up assessment items: General conditions, such as feeding status, medical history during the follow-up period, weight, height, head circumference, chest circumference, vision, blood routine, trace elements, etc.;

Secondary

MeasureTime frame
Clinical data: Information such as gender, gestational age, birth weight, age, mode of delivery, Apgar score, maternal gravidity and parity, maternal pregnancy complications, amniotic fluid status, placental status, resuscitation measures received, and antibiotic usage, as well as the disease conditions in preterm infants.;Neuropsychological development assessment items, such as General Movements Assessment (GMS) , Alberta Infant Motor Scale (AIMS) , and Griffiths Scales of Child Development for detection.;

Countries

China

Contacts

Public ContactEnfu Tao/Haiting Li

Wenling Maternal and Child Health Care Hospital

11918403@zju.edu.cn+86 576 8616 8039

Outcome results

None listed

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