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Effect of hydrolyzed formula and standard formula in the first two weeks of life in preterm infants

Comparative study of the effect of hydrolyzed formula and standard formula in the first two weeks of life in preterm infants less than 34 weeks on improving nutritional tolerance and the prevalence of necrotizing enterocolitis.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20160120026115N7
Enrollment
104
Registered
2022-01-17
Start date
2020-11-21
Completion date
Unknown
Last updated
2022-02-07

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

Conditions

Necrotizing enterocolitis. Necrotizing enterocolitis in newborn, unspecified

Interventions

Intervention 1: In the intervention group, the hydrolyzed formula is used for feeding in all meals. The hydrolyzed formula in all members of the intervention group was from the same brand (Aptamil / N

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 14 Days

Inclusion criteria

Inclusion criteria: Infants less than 34 weeks gestationally deprived of breast milk Infants without underlying congenital disorders

Exclusion criteria

Exclusion criteria: Infants were excluded from the study with parental dissatisfaction. Infants from addicted parents were excluded from the study. Infants with asphyxia were excluded from the study. Infants with a fifth minute Apgar score of less than seven were excluded from the study. Infants with IUG-R were excluded from the study. Infants with congenital anomalies were excluded from the study.

Design outcomes

Secondary

MeasureTime frame
Duration of hospital stay. Timepoint: From the start of feeding the baby to the time of discharge from the hospital. Method of measurement: Number of days of hospitalization based on the contents of the file.;Sepsis. Timepoint: From the start of feeding the baby to the time of discharge from the hospital. Method of measurement: Positive blood culture.

Primary

MeasureTime frame
Improvement in nutritional tolerance. Timepoint: From the start of feeding the baby to the time of discharge from the hospital. Method of measurement: Clinical examination corresponding to the disease.;Reducing the incidence of necrotizing enterocolitis in premature infants. Timepoint: From the start of feeding the baby to the time of discharge from the hospital. Method of measurement: Clinical and laboratory examination corresponding to the disease.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMandana Kashaki

Iran University of Medical Sciences

kashakimd@gmail.com+98 21 5563 2277

Outcome results

None listed

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