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Effects of early initiation of colostrum on outcomes in preterm infants

Assessing the effects of early initiation of colostrum for prevention of sepsis in premature infants

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20151020024625N20
Enrollment
112
Registered
2024-06-02
Start date
2024-06-21
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

Early and late onset sepsis. Bacterial sepsis of newborn

Interventions

Intervention 1: Intervention group: In the intervention group, in addition to TPN, the mother's colostrum is taken immediately after birth, and in the first hours of admission in the NICU, 0.2 ml of c

Sponsors

Semnan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 223 Days

Inclusion criteria

Inclusion criteria: Gestational age at birth less than 32 weeks. Birth weight greater than or equal to 1500 gram.

Exclusion criteria

Exclusion criteria: Contraindication for breastfeeding APGAR score less than 5 Umbilical cord arterial pH less than 7 at the first hour of birth Birth asphyxia. Congenital gastrointestinal (GI) anomalies

Design outcomes

Primary

MeasureTime frame
Early onset sepsis. Timepoint: Seven, and 14 days after initiation of the intervention. Method of measurement: Laboratory tests including blood cultures and clinical examinations and the presence of symptoms such as fever, lethargy, and respiratory symptoms.

Secondary

MeasureTime frame
Late onset sepsis. Timepoint: 21 days after initiation of the intervention and finally until start of normal nutrition and cessation of total parenteral nutrition (TPN). Method of measurement: Laboratory tests including blood cultures and clinical examinations and the presence of symptoms such as fever, lethargy, and respiratory symptoms.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactYalda Taghipour

Semnan University of Medical Sciences

Ya.taghipour20@gmail.com+98 23 3346 0055

Outcome results

None listed

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