Protein supplement effect on the growth and immune system in preterm infants .

Study of varying protein supplement effect on the growth criteria and maturation of immune system in very low birth weight infants .

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016041927474N1

Enrollment

Registered

2016-05-21

Start date

2015-12-21

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

growth and immune disorders in preterm infants. P05,P07

Interventions

Intervention 1: Intervention group 1:added protein supplement (4.8 mg/kg/day) )from Aptamil company in 100 cc breast milk and used daily for 21 day. this supplement contain whey and casein protein. I

Intervention group 1:added protein supplement (4.8 mg/kg/day) )from Aptamil company in 100 cc breast milk and used daily for 21 day. this supplement contain whey and casein protein.

Intervention group 2:added protein supplement (3.5 mg/kg/day) )from Aptamil company in 100 cc breast milk and used daily for 21 day. this supplement contain whey and casein protein.

Control group without any supplement and placebo

Eligibility

Sex/Gender

All

Age

1 Days to 30 Days

Inclusion criteria

Inclusion criteria: Enclusion criteria:Preterm infant with w<1500 gr and gestional age<32 weeks that admit in NICU (Hajar Hospital) from Desember 2015 until May 2016. Exclusion critaria:Congenital malformations; NEC; Major surjery; Intra uterian infections; Koromosomal disorders; Sepsis.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Weight. Timepoint: Pre intervention and daily to end of intervention. Method of measurement: Digitaly scale /gram.;Head circumambient. Timepoint: Pre intervention,first and second week and end of intervention. Method of measurement: Non elastic meter/cm.;Length. Timepoint: Pre intervention,first and second week and end of intervention. Method of measurement: Non elastic meter/cm.;Neutrophil cell count. Timepoint: Pre and post intervention. Method of measurement: cbc.diff %.;Lymphocyte. Timepoint: Pre and post intervention. Method of measurement: cbc.diff %.;IgG. Timepoint: Pre and post intervention. Method of measurement: ELISA/mg/dl.;IgM. Timepoint: Pre and post intervention. Method of measurement: ELISA/mg/dl.;IgA. Timepoint: Pre and post intervention. Method of measurement: ELISA/mg/dl.	—

Measure

Time frame

Weight. Timepoint: Pre intervention and daily to end of intervention. Method of measurement: Digitaly scale /gram.;Head circumambient. Timepoint: Pre intervention,first and second week and end of intervention. Method of measurement: Non elastic meter/cm.;Length. Timepoint: Pre intervention,first and second week and end of intervention. Method of measurement: Non elastic meter/cm.;Neutrophil cell count. Timepoint: Pre and post intervention. Method of measurement: cbc.diff %.;Lymphocyte. Timepoint: Pre and post intervention. Method of measurement: cbc.diff %.;IgG. Timepoint: Pre and post intervention. Method of measurement: ELISA/mg/dl.;IgM. Timepoint: Pre and post intervention. Method of measurement: ELISA/mg/dl.;IgA. Timepoint: Pre and post intervention. Method of measurement: ELISA/mg/dl.

—

Secondary

Measure	Time frame
PH. Timepoint: Pre intervention,first and second week and post intervention. Method of measurement: ABG/m. mol.;BUN. Timepoint: Pre intervention,first and second week and post intervention. Method of measurement: BLOOD SAMPLE/mg/dl.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Majid Hamidi

Shahrekord University Of Medical Sciences

M.hamidi@skums.ac.ir+98 38 3222 0016

Outcome results

None listed

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