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Verification of Application Effects and Cost-Effectiveness Analysis of Breast Milk Enema for Full Enteral Feeding in Preterm Infants: A Randomized Controlled Trial

Verification of Application Effects and Cost-Effectiveness Analysis of Breast Milk Enema for Full Enteral Feeding in Preterm Infants: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500105314
Enrollment
Unknown
Registered
2025-07-01
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-07-07

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

Conditions

Time to full enteral feeding

Interventions

Observation Group :breast milk enema
Control Group:Glycerol Diluent Enema

Sponsors

Southwest Medical University Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: 1. Low Birth Weight Infant (LBW): Live-born infant with birth weight < 2,500 g 2. Very Low Birth Weight Infant (VLBW): Live-born infant with birth weight < 1,500 g 3. Extremely Low Birth Weight Infant (ELBW): Live-born infant with birth weight < 1,000 g 4. Mother able to provide breast milk 5. Written informed consent obtained from the infant's parents

Exclusion criteria

Exclusion criteria: 1. Presence of severe conditions: Congenital malformations, congenital gastrointestinal anomalies, anorectal malformations, diarrhea, intussusception, necrotizing enterocolitis (NEC), patent ductus arteriosus (PDA), sepsis, neutropenia, or coagulation disorders. 2. Spontaneous passage of meconium within 48 hours after birth.

Design outcomes

Primary

MeasureTime frame
Full Enteral Feeding Time (FEF) Time to Complete Meconium Evacuation (TCME);

Secondary

MeasureTime frame
Duration of Parenteral Nutrition (DPN),Length of Hospital Stay (LOS),Discharge Weight,Complication Incidence: necrotizing enterocolitis (NEC), bowel perforation, secondary neonatal hyperbilirubinemia induced by feeding/enema procedures, feeding intolerance, etc.Post-discharge Outcomes (1-year):Readmission Frequency for feeding-related issues (e.g., malnutrition, gastrointestinal infections),Total Readmission Days;

Countries

China

Contacts

Public ContactZHANG Guoyan

Southwest Medical University Affiliated Hospital

1281444959@qq.com+86 133 4074 6518

Outcome results

None listed

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