None
Conditions
Interventions
HMOs group:Feeding with HMOs Supplement
Placebo group:Feeding with placebo supplement
Sponsors
Department of Pediatrics, The First Medical Center, General Hospital of the People's Liberation Army of China
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Preterm infants born between 32 and 37 weeks of gestation, with a birth weight of < 2500 grams, and infants less than 7 days old were included in the study; 2.Clinically stable (defined as not receiving any invasive respiratory support, no patent ductus arteriosus requiring treatment, no early-onset sepsis or severe intrauterine growth restriction at birth, and not currently using vasopressors to support hemodynamics); 3.Able to attend follow-up appointments on time and cooperate with various scale assessments; 4.Able to tolerate standard cow's milk-based infant formula without any probiotics at the time of enrollment; 5.Parents/guardians do not intend to change the feeding regimen before the study concludes and have signed a written informed consent.
Exclusion criteria
Exclusion criteria: 1.Infants requiring a diet outside of the prescribed feeding regimen; 2.A history of maternal, fetal, or participant conditions or diseases that may increase the risk of participation in this study, or have potential impacts on gastrointestinal tolerance, growth, and/or development; 3.Infants receiving ongoing prophylactic antifungal treatment or with early-onset sepsis or liver failure prior to enrollment; 4.Allergy to components of HMOs, diagnosed with cow’s milk protein allergy, or other allergic conditions; 5.Infants with medical conditions or histories that may increase the risk of participation or interfere with the interpretation of study results (including evidence of major congenital malformations, suspected or documented systemic or congenital infections, history of NICU admission except for phototherapy due to jaundice, or other severe medical or laboratory abnormalities); 6.Infants currently or previously receiving probiotic supplements or any medication or supplements known or suspected to affect fat digestion, absorption, and/or metabolism, stool characteristics, growth, or gastric acid secretion; 7.Parents refusing participation after informed consent; 8.Inability to comply with scheduled visits and feeding requirements of the study protocol; 9.Infants currently or previously participating in other clinical trials; 10.Other conditions judged by the investigator as unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anthropometrics(Weight gain from baseline to 4 weeks post-intervention);Infant intestinal flora; | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional anthropometrics (weight, length, head circumference and corresponding z-scores);Gastrointestinal symptoms and faecal characteristics;Changes in fecal characteristics; | — |
Countries
China
Contacts
Public ContactHui Long
Department of Pediatrics, The First Medical Center, General Hospital of the People's Liberation Army of China
Outcome results
None listed