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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03100305
Other study ID # XH-17-001
Secondary ID
Status Completed
Phase
First received February 21, 2017
Last updated March 30, 2018
Start date January 1, 2017
Est. completion date March 20, 2018

Study information

Verified date March 2018
Source Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 124
Est. completion date March 20, 2018
Est. primary completion date February 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Amino acid profiles in blood Amino acid levels in blood through the transition to enteral nutrition, an average of 1 month
Secondary Weight Until the corrected gestational age is 37 weeks or discharged
Secondary Height Until the corrected gestational age is 37 weeks or discharged
Secondary Head circumference Until the corrected gestational age is 37 weeks or discharged
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