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Evaluation of oral GCSF effects on Gastrointestinal deveopment in preterm infants

Comparison of the effect of oral granulocyte colony stimulating factor (G-CSF) on the development of the gastrointestinal tract of preterm infants weighing less than 1500 g with the same group receiving placebo

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190622043967N1
Enrollment
60
Registered
2020-08-10
Start date
2020-09-22
Completion date
Unknown
Last updated
2020-09-07

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

Conditions

Gastrointestinal immaturity in neonates. Other vomiting of newborn.

Interventions

Intervention 1: Intervention group: After obtaining the informed consent of the parents of the infants when the order to start feeding is given by the neonatal specialist, the order to start oral filg

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 259 Days

Inclusion criteria

Inclusion criteria: The baby is premature The birth weight of the baby is less than 1500 grams It is possible to start feeding in the first three days of life The baby does not have sepsis The baby does not have a congenital major anomaly A written consent form has been obtained from the parents

Exclusion criteria

Exclusion criteria: The baby has congenital major anomalies The baby has a gastrointestinal anomaly The baby has necrotizing enterocolitis The baby has cyanotic heart disease The baby has primary sepsis Apgar score at birth is less than 6

Design outcomes

Primary

MeasureTime frame
The amount of regenerative substances in the feces of infants. Timepoint: End of the first, second and third week. Method of measurement: Stool Exam.;Infant stool pH. Timepoint: End of the first, second and third week. Method of measurement: Stool Exam.;Trypsin concentration in neonatal feces. Timepoint: End of the first, second and third week. Method of measurement: Stool Exam.;Elastase levels in neonatal feces. Timepoint: End of the first, second and third week. Method of measurement: Stool Exam.;Number of WBCs in stool samples. Timepoint: End of the first, second and third week. Method of measurement: Stool Exam.;Number of RBCs in stool samples. Timepoint: End of the first, second and third week. Method of measurement: Stool Exam.;Blood TG level. Timepoint: End of the first, second and third week. Method of measurement: Taking a blood sample.;The amount of total protein in the blood. Timepoint: End of the first, second and third week. Method of measurement: Taking a blood sample.;Blood albumin level. Timepoint: End of the first, second and third week. Method of measurement: Taking a blood sample.;Hb level of blood. Timepoint: End of the first, second and third week. Method of measurement: Taking a blood sample.;WBC blood count. Timepoint: End of the first, second and third week. Method of measurement: Taking a blood sample.

Secondary

MeasureTime frame
Time to reach a tolerance of 50 ml/kg of milk in newborns. Timepoint: Daily. Method of measurement: Checking the infant hospitalization file.;Time to reach a tolerance of 75 ml/kg of milk in newborns. Timepoint: Daily. Method of measurement: Checking the infant hospitalization file.;Time to reach a tolerance of 100 ml/kg of milk in newborns. Timepoint: Daily. Method of measurement: Checking the infant hospitalization file.;Time to reach a tolerance of 150 ml/kg of milk in newborns. Timepoint: Daily. Method of measurement: Checking the infant hospitalization file.;Duration of NPO in infants. Timepoint: End of study. Method of measurement: Checking the infant hospitalization file.;Time to reach birth weight in infants. Timepoint: End of study. Method of measurement: Checking the infant hospitalization file.;??? ??? ????? ???????. Timepoint: End of study. Method of measurement: Checking the infant hospitalization file.;Duration of intravenous feeding in infants. Timepoint: End of study. Method of measurement: Checking the infant hospitalization file.;Duration of antibiotic administration in infants. Timepoint: End of study. Method of measurement: Checking the infant hospitalization file.;Occurrence of necrotizing enterocolitis (NEC). Timepoint: Daily. Method of measurement: Clinical examination and View radiographic photos if necessary.;Occurrence of systemic infection (sepsis) in newborns. Timepoint: Daily. Method of measurement: Clinical examination and observation of tests if necessary.;Occurrence of infant mortality. Timepoint: End of study. Method of measurement: Checking the infant hospitalization file.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAshraf Alsadat Mousavi

Iran University of Medical Sciences

mousavi.a@iums.ac.ir+98 21 5590 2070

Outcome results

None listed

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