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A prospective randomized controlled clinical study of nutritional intervention in high-risk infants

A prospective randomized controlled clinical study of nutritional intervention in high-risk infants

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043882
Enrollment
Unknown
Registered
2021-03-04
Start date
2021-05-01
Completion date
Unknown
Last updated
2021-07-05

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

Conditions

High-risk infants

Interventions

Experimental group:High-calorie nutritional formula
Control group:Breast milk or normal fomula

Sponsors

Guangzhou Women and Children's Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: 1. Infants affected by any high-risk factors in the preconception, fetal period, delivery period, and neonatal period; 2. Corrected age between 0 to 12 months; 3. Malnutrition according to the WHO Growth and Development Standard. 4. Parents sign informed consent The high-risk factors incliding: (1) Preconception high-risk factors:pregnant mother aged 40 years old,the pregnant mother had smoking, drug or alcohol history,the pregnant mother had a history of stillbirth, miscarriage, premature delivery, etc. (2) High-risk factors during the fetal period: history of threatened abortion, history of infection, intrauterine growth restriction, multiple births, history of drug use, etc. (3) High-risk factors during delivery period: dystocia, asphyxia, jaundice, infection, etc. (4) High-risk factors in the neonatal period: premature birth or low birth weight, congenital defects, hypoxic-ischemic encephalopathy, infection, accidental or non-accidental brain injury, etc.

Exclusion criteria

Exclusion criteria: 1. Serious cardiovascular, liver, kidney and hematopoietic diseases; 2. Serious surgical complications; 3. Long-term parenteral nutrition due to gastrointestinal dysfunction.

Design outcomes

Primary

MeasureTime frame
Weight;Height;Head circumference;

Countries

China

Contacts

Public ContactKaishou Xu

Guangzhou Women and Children's Medical Center

xksyi@126.com+86 13422250582

Outcome results

None listed

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