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Application and follow-up of extensively hydrolysed cows' milk protein formula in preterm infants

Application and follow-up of extensively hydrolysed cows' milk protein formula in preterm infants

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-14005696
Enrollment
Unknown
Registered
2014-11-14
Start date
2014-11-28
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

preterm

Interventions

observation group:feeding extensively hydrolyzed cows' milk protein formulas(100% Whey protein)
comparison group:feeding standard preterm formulas

Sponsors

Zhong Da Hospital affiliated Southeast University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Gestational age less than 34 weeks; 2. Only can formula feeding for mother's disease; 3. Do not add any enteral feeding before transporting to our NICU, including any glucose, water or milk; 4. Cardiovascular, circulatory and nervous system was stable before transporting to our NICU.

Exclusion criteria

Exclusion criteria: 1. Before the feeding there is vomiting, abdominal distension, gastrointestinal bleeding, necrotizing enterocolitis (NEC); 2. Digestive tract malformation (esophageal atresia, tracheo-esophageal fistula, biliary atresia, congenital hirschsprung's disease, anorectal atresia, gastroschisis, umbilical prolapse, congenital malformation etc.); 3. Inherited metabolic diseases and chromosome abnormality; 4. Severe congenital disorders (diaphragmatic hernia, cyanotic congenital heart disease, moderate to severe Pierre-Robin syndrome); 5. Before the feeding the circulatory, cardiovascular and neurological system was unstable (e.g.: shock, disseminated intravascular coagulation, frequent seizures, and coma); 6. Renal failure due to various reasons; 7. Head CT scan or B ultrasound showed severe intracranial hemorrhage or hydrocephalus; 8. Previously or are currently using drugs affecting gastrointestinal peristalsis and gastric acid secretion (H2 receptor antagonists and proton pump inhibitors, gastrointestinal motility drug); 9. During hospitalization the baby was diagnosed with Necrotizing enterocolitis III and was transfer to the children's Hospital for further treatment; 10. Clinical therapy for enteral nutrition adjustment (we can change the protein hydrolysate formulas into premature formulas and the latter can also be replaced by the former); 11. During the period of hospitalization occur death; 12. Due to various reasons the patient was discharged earlier; 13. Missed follow-up period; 14. During the follow up the patient was diagnosed with a severe disease and need to be admitted to the intensive care unit for further treatment or surgery; 15. Death on account of various causes during the follow-up period.

Design outcomes

Primary

MeasureTime frame
incidence of feeding intolerance;

Secondary

MeasureTime frame
time of reaching full enteral feeding;time of parenteral nutrition;time of defecating meconium;daily stool frequency;number of total required enema;number of required enema/day;growth velocity rate in weight;growth velocity rate in length;growth velocity rate in head circumference;Head circumference;hospitalization in NICU;value of plasma total protein before discharge;value of plasma albumin before discharge;calcium concentration before discharge;phosphorus concentration before discharge;value of plasma alkaline phosphatase before discharge;

Countries

China

Contacts

Public ContactLiping Yin
1035012153@qq.com+86 18260058456

Outcome results

None listed

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