|
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:
|
TCTR |
|
Last refreshed on:
|
29 April 2024 |
|
Main ID: |
TCTR20170401001 |
|
Date of registration:
|
01/04/2017 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
The effects of warm saline rectal irrigation on feeding intolerance in preterm infants: a randomized controlled trial
|
|
Scientific title:
|
The effects of warm saline rectal irrigation on feeding intolerance in preterm infants: a randomized controlled trial |
|
Date of first enrolment:
|
07/02/2017 |
|
Target sample size:
|
64 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://www.thaiclinicaltrials.org/show/TCTR20170401001 |
|
Study type:
|
Interventional |
|
Study design:
|
Randomized
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Thailand
| | | | | | | |
|
Contacts
|
|
Name:
|
Pailin -
Sakornnaweechai |
|
Address:
|
Building 1, 270 Rama IV Road,Thung Phaya Thai Ratchathewi Bangkok 10400.
10400
Bangkok
Thailand |
|
Telephone:
|
+6685-403-0716 |
|
Email:
|
pailin_2921@hotmail.com |
|
Affiliation:
|
Mahidol University Faculty of Medicine Ramathibodi Hospital |
|
|
Name:
|
Pailin -
Sakornnaweechai |
|
Address:
|
Building 1, 270 Rama IV Road,Thung Phaya Thai Ratchathewi Bangkok 10400.
10400
Bangkok
Thailand |
|
Telephone:
|
+6685-403-0716 |
|
Email:
|
pailin_2921@hotmail.com |
|
Affiliation:
|
Mahidol University Faculty of Medicine Ramathibodi Hospital |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: •Premature infants with a birth weight < 1500 g or a gestational age (GA) <32 weeks
•Did not pass meconium or pass thin smear 1-2 times during the first 48 hr of life
Exclusion criteria: •major congenital malformations
•known gastrointestinal abnormalities
•Infant with hemodynamic instability
Age minimum:
0 N/A (No limit)
Age maximum:
0 N/A (No limit)
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
warm saline rectal irrigation, feeding intolerance, preterm, meconium passage
|
preterm with delayed meconium passage and feeding intolerance
warm saline rectal irrigation, feeding intolerance, preterm, meconium passage
|
|
Intervention(s)
|
|
Experimental Procedure/Surgery,Sham Comparator Procedure/Surgery
|
|
rectal irrigation,sham procedure
|
|
The infants in intervention group were administered warm saline enema once a day until completed evacuation of meconium but not exceed 5 days.The procedure was done behind the curtains with NO.8 OG feeding tube and 10 ml syringe, lubricated with KY jelly and gentlely inserted into the rectum until the catheter can not pass more then slowly push warm saline and aspirate meconium until the aspirated fluid was clear. ,The infants in the control group were performed sham procedure (open and closed pampers ) behind the curtain.
|
|
Primary Outcome(s)
|
|
Full enteral feeding was achieved (volumes 150 ml/kg/day) for 72 hrs Time to full enteral feeding was achieved (volumes 150 ml/kg/day) for 72 hrs duration ,Feeding intolerance 10 days Occasions feeds withheld, Occasions feeds reduced, gastric content
|
|
Secondary Outcome(s)
|
|
Time to first pass of meconium first pass of meconium duration,Time to complete meconium evacuation complete meconium evacuation duration,Duration of hospital stay hospital discharge duration,Duration of phototherapy hospital discharge duration,Mortality rate before end of study number
|
|
Source(s) of Monetary Support
|
|
Division of neonatology, pediatric department, Mahidol University Faculty of Medicine Ramathibodi Ho
|
|
Ethics review
|
Status: Submitted, approved
Approval date:
Contact:
raec.mahidol@gmail.com
Institutional Review Board (IRB) of Faculty of Medicine Ramathibodi Hospital
+662-2011544 Ext.
raec.mahidol@gmail.com
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
28/02/2018 |
|
URL:
|
|
|
|