|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ChiCTR |
|
Last refreshed on:
|
11 September 2017 |
|
Main ID: |
ChiCTR-DDD-17012625 |
|
Date of registration:
|
2017-09-09 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Characteristics of gastrointestinal function in preterm infants and its relationship with feeding intolerance
|
|
Scientific title:
|
Characteristics of gastrointestinal function in preterm infants and its relationship with feeding intolerance |
|
Date of first enrolment:
|
2016-01-01 |
|
Target sample size:
|
Target condition:45;Difficult condition:0 |
|
Recruitment status: |
Completed |
|
URL:
|
http://www.chictr.org.cn/showproj.aspx?proj=21405 |
|
Study type:
|
Diagnostic test |
|
Study design:
|
Diagnostic test for accuracy
|
|
Phase:
|
Diagnostic New Technique Clincal Study
|
|
|
Countries of recruitment
|
|
China
| | | | | | | |
|
Contacts
|
|
Name:
|
Wujuan Hao
|
|
Address:
|
468 Yanling Middle Road, Tianning, Changzhou, Jiangsu, China
213000
|
|
Telephone:
|
+86 18862931287 |
|
Email:
|
1753669375@qq.com |
|
Affiliation:
|
Nantong University Affiliated Children's Hospital of Changzhou |
|
|
Name:
|
Wenjuan Tu
|
|
Address:
|
468 Yanling Middle Road, Tianning, Changzhou, Jiangsu, China
213000
|
|
Telephone:
|
+86 13915043598 |
|
Email:
|
tuwenjuan2008@163.com |
|
Affiliation:
|
Nantong University Affiliated Children's Hospital of Changzhou |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: 1.preterm infants:birth weight =2000g;infants with 28 weeks2.term infants within 7 days after birth ,gestational age>37 weeks,birth weight>2000g,no obvious intrapartum asphyxia, no gastrointestinal diseases, generally were in good condition.
Exclusion criteria: Infants with birth defects (gastrointestinal malformations, congenital heart disease); intestinal obstruction, gastrointestinal bleeding and other diseases of the digestive system; with critical illness were excluded.
Age minimum:
Age maximum:
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
feeding intolerance
|
|
Intervention(s)
|
|
Gold Standard:Clinical outcomes: FI diagnostic criteria is that: vomiting is greater than or equal to 3 times/day; the amount of milk does not increase or decrease over 3 days; abdominal distension, that is the abdominal circumference increased 1.5cm/ days; gastric residual amount exceeds 30% of the previous feeding volume&#;Index test:Ultrasound was used to evaluate the gastrointestinal motility. The gastric secretion function was evaluated by testing the PH and pepsinogen of gastric juice.;
|
|
Primary Outcome(s)
|
|
gastric emptying rate;motility index;PH value of gastric juice;pepsinogen;
|
|
Source(s) of Monetary Support
|
|
the Maternal and Child health research project of Jiangsu Province
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|