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The effect of nutritional protein on premature neonates' growth

Comparing usual protein and rich protein regimens on growth among premature neonates weighed less than 1500 gram: a double blind randomized clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180923041095N1
Enrollment
72
Registered
2018-11-11
Start date
2017-02-19
Completion date
Unknown
Last updated
2019-01-14

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

Conditions

Immaturity in neonates. Preterm [premature] newborn [other]

Interventions

Intervention 1: Intervention group: the neonates received protein 4-5 gr/kg/day. They received this amount through breast milk in addition to Aptamil human milk fortifier and protein supplement. In th

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 30 Days

Inclusion criteria

Inclusion criteria: Preterm neonates with birth weight less than 1500 gram Reaching full enteral feeding with either fortified Breast milk (FBM) or preterm formula (PF)

Exclusion criteria

Exclusion criteria: Intra ventricular hemorrhage grade III or more Any condition such as heart failure or large PDA that affected callory requirement in neonate Any gastrointestinal anomaly

Design outcomes

Primary

MeasureTime frame
Weight. Timepoint: Before intervention and daily until discharge. Method of measurement: Seca 345 scale.;Head circumference. Timepoint: Before intervention and daily until discharge. Method of measurement: tape measure.;Length. Timepoint: Before intervention and daily until discharge. Method of measurement: tape measure.

Secondary

MeasureTime frame
Albumin. Timepoint: Before intervention, at the time of reaching full fed amount and then weekly until discharge. Method of measurement: Lab blood test.;Blood urea nitrogen (BUN). Timepoint: Before intervention, at the time of reaching full fed amount and then weekly until discharge. Method of measurement: Lab blood test.;Blood gases. Timepoint: Before intervention, at the time of reaching full fed amount and then weekly until discharge. Method of measurement: Lab blood test.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaral Ghasemzadeh

Shiraz University of Medical Sciences

maral.ghasemzade1984@gmail.com+98 21 8824 8732

Outcome results

None listed

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