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High Protein and High Energy Intakes and Physical Activity on Growth of Extremely Low Birth Weight Infants

NCT03374033 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2019-05-09

No results posted yet for this study

Summary

The aim of this study is to evaluate the effect of increasing amino acid and energy intake during parenteral and enteral nutrition with and without the stimulation of the infant's physical activity, on growth of extremely low birth weight infants .

Conditions

  • Infant, Very Low Birth Weight

Interventions

DIETARY_SUPPLEMENT

NUTR +

one extra g/kg/d of protein and lipids starting before 48 hours after birth until 36 weeks postmenstrual age

BEHAVIORAL

STIMUL +

Physical activity stimulation consists in flexion/extension of the 4 limbs and other motion exercises of the shoulder girdle and of the hips. This stimulation will take place before the feed for a mean of 30 times a week (minimum 24- maximum 36 times a week, 10 minutes each time) and will start within the 10th day of life until 36 weeks postmenstrual age

Sponsors & Collaborators

  • Università Politecnica delle Marche

    lead OTHER

Principal Investigators

  • Virgilio P. Carnielli, MD, PhD · Università Politecnica delle Marche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
24 Weeks
Max Age
32 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-10
Primary Completion
2020-04-03
Completion
2022-07-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03374033 on ClinicalTrials.gov