Amino Acids Profiles in Premature Infants Receiving Nutritional Support

NCT03100305 | Completed

• 1 other identifier: XH-17-001
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Premature Infant

Outcome Measures

Primary Outcomes (1)

• Amino acid profiles in blood

  Amino acid levels in blood

  through the transition to enteral nutrition, an average of 1 month

Secondary Outcomes (3)

• Weight

  Until the corrected gestational age is 37 weeks or discharged

• Height

  Until the corrected gestational age is 37 weeks or discharged

• Head circumference

  Until the corrected gestational age is 37 weeks or discharged

Study Arms (4)

Extremely preterm infants

Other: Collection of blood and urine

Very preterm infants

Other: Collection of blood and urine

Moderately preterm infants

Other: Collection of blood and urine

Late preterm infants

Other: Collection of blood and urine

Interventions

Collection of blood and urine OTHER

Collection of blood and urine before nutritional support, during total parenteral nutrition, during partial parenteral nutrition and during enteral nutrition

Extremely preterm infants; Late preterm infants; Moderately preterm infants; Very preterm infants

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

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

Shanghai, China

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Urination

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Zhenjuan He, master

  Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director of neonatal department

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: April 4, 2017
• Study Start: January 1, 2017
• Primary Completion: February 15, 2018
• Study Completion: March 20, 2018
• Last Updated: April 3, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)