Amino Acids Profiles in Premature Infants Receiving Nutritional Support

March 30, 2018 updated by: Zhenjuan He, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

A Prospective Study of Amino Acids Profiles in Premature Infants Receiving Nutritional Support

The aim of this study is to investigate the changes of amino acid metabolic profiles in different nutritional stages of preterm infants and determine the effects of nutritional intervention on the amino acid metabolic status of preterm infants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

124

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Preterm infants who experience various nutritional stages including total parenteral nutrition, partial parenteral nutrition and enteral nutrition

Description

Inclusion Criteria:

Premature infants, and admitted to hospital within 24 hours after birth; Documentation of informed consent; In need of receiving parenteral nutrition after birth;

Exclusion Criteria:

Premature infants with a parenteral nutrition period of less than 3 days; Inborn error of metabolism; Chromosomal abnormalities or multiple malformations;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Extremely preterm infants
Other: Collection of blood and urine
Collection of blood and urine before nutritional support, during total parenteral nutrition, during partial parenteral nutrition and during enteral nutrition
Very preterm infants
Other: Collection of blood and urine
Collection of blood and urine before nutritional support, during total parenteral nutrition, during partial parenteral nutrition and during enteral nutrition
Moderately preterm infants
Other: Collection of blood and urine
Collection of blood and urine before nutritional support, during total parenteral nutrition, during partial parenteral nutrition and during enteral nutrition
Late preterm infants
Other: Collection of blood and urine
Collection of blood and urine before nutritional support, during total parenteral nutrition, during partial parenteral nutrition and during enteral nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amino acid profiles in blood
Time Frame: through the transition to enteral nutrition, an average of 1 month
Amino acid levels in blood
through the transition to enteral nutrition, an average of 1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Weight
Time Frame: Until the corrected gestational age is 37 weeks or discharged
Until the corrected gestational age is 37 weeks or discharged
Height
Time Frame: Until the corrected gestational age is 37 weeks or discharged
Until the corrected gestational age is 37 weeks or discharged
Head circumference
Time Frame: Until the corrected gestational age is 37 weeks or discharged
Until the corrected gestational age is 37 weeks or discharged

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Zhenjuan He, master, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

February 15, 2018

Study Completion (Actual)

March 20, 2018

Study Registration Dates

First Submitted

February 21, 2017

First Submitted That Met QC Criteria

March 28, 2017

First Posted (Actual)

April 4, 2017

Study Record Updates

Last Update Posted (Actual)

April 3, 2018

Last Update Submitted That Met QC Criteria

March 30, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XH-17-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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