Comparision of Two Different Feeding Method in Preterms

Enteral Feeding Intolerance Clinical Trial

Official title:

Comparision of Two Different Feeding Method in Preterm Infants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05265143
• Other study ID #: 2579
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: June 1, 2022

Study information

• Verified date: February 2022
• Source: Zekai Tahir Burak Women's Health Research and Education Hospital
• Contact: funda atay
• Phone: +905054409167
• Email: funday.atay[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

achievement of optimal postnatal growth by adequate enteral nutrition in critically ill preterm infants is a challenge of NICU. signs like abdominal distension, reflux, vomiting, nec is a factors of discontinuing fedding in preterm. this factors plays a role in decisions about which method of gavage feeding is adopted. we compare two different feeding method to achive less fedding tolerence.

Description:

<1750 gr, <33 gw infants will enroll study. exckusion criteria: major congenital anomalies major gis anomalies

The study infants are enrolled within 24 hours of birth and sequently randomized to either intermitten feeding (IF) and bolus feeding (BF). Intermittent feeding is defined as delivering enteral nutrition and generally giving 60 min and 2 hours no feeding. this circle repeats 8 times in 24 hours. Bolus feeding is the amount of nutrition put into the syringe was kept 10 cm above the baby and the fluidity was obtained by gravity through the orogastric tube. The data of the patients such as feeding intolerance (gastric residual volume more than %50 of the previous feeding volume, gastric regurgitation, abdominal distension and/or emesis ), whether there is a week-by-week feeding intolerance were noted, NEC, time to reached birth weight, time to achieved full enteral feeding, every 5 minutes during feeding, saturation, respiratory rate and heart rates will record.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Days

Eligibility

Inclusion Criteria:

• <1750 gr preterm infants

• <33 gw

• admitted to our nicu in first day of life

Exclusion Criteria:

major congenital anomalies gis anomalies septic shock exitus in 3 days of life

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Related Conditions & MeSH terms

• Enteral Feeding Intolerance
• Premature Birth

Intervention

Other:
• bolus/intermittant feeding
sequential randomization

Locations

Country	Name	City	State
Turkey	Ümraniye Teaching Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Zekai Tahir Burak Women's Health Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Richards R, Foster JP, Psaila K. Continuous versus bolus intermittent intragastric tube feeding for preterm and low birth weight infants with gastro-oesophageal reflux disease. Cochrane Database Syst Rev. 2021 Aug 6;8:CD009719. doi: 10.1002/14651858.CD009719.pub3. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of feeding intolerence	The effect of two different gavage tube feeding methods on feeding intolerance	1 month
Secondary	time to reach full enteral feeding	The effect of two different gavage tube feeding methods on time to reach full enteral feeding	1 month