Comparative Study Between Two Routes of Enteral Feeding

NCT04576234 | Unknown DMC

• 3 other identifiers: enteral feedingsasmaaMostafa Samy
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The study assess, evaluate and compare the efficacy of two methods of enteral feeding on complications and nutritional status among ICU patients. The study had utilized two methods of enteral feeding consisted of intermittent enteral feeding by syringe pump and hospital blended enteral feeding by feeding bag and assess the patient before and after feeding for 10 days by using three tools help to monitor hemodynamic parameters, GIT system assessment and laboratory findings assessment which help to evaluate nutritional status and complications. The results showed that the complications in the intermittent enteral feeding group were lower than those in feeding bag group.

Conditions

Complication

Keywords

intermittent enteral feeding; hospital blended feeding; complications; nutritional status

Outcome Measures

Primary Outcomes (2)

• change in serum protein level

  by using serum protein test which will be assessed daily, there will be change in the serum protein level to the normal value

  for 10 days

• change in the rate of complications

  by using evaluation outcomes tool , complications will be assessed 3 times through the study

  for 10 days

Study Arms (2)

intermittent entral feeding group

EXPERIMENTAL

Intermittent enteral feeding group recieved intermittent feeding as the feed was given over a 24 hour period with intervals of rest (e.g. three hours feeding two hours rest) by using syringe pump and Feeds were administered according to guidelines as the head of the patient's bed was elevated at least 30 degrees from the horizontal before initiating feeding, the feeding schedule was started at a rate of 50 ml/hr in adults to promote tolerance,the administration rate of isotonic formulas increased in 20-25 ml/hr increments every eight hours until the desired rate was achieved, the tube was flushed regularly with 20 to 30 ml of warm water every four hours during continuous feeding and before and after intermittent feeding and medication administration, the gastric residual volume was checked every 4-6 hr routinely

Dietary Supplement: entral feeding

, feeding bag group

EXPERIMENTAL

Feeding bag group received hospital blended formual which was 300 ml of feeds every 2hrs with 4hrs rest at night and given in 10 minutes with following the same guidelines in the intermittent enteral feeding group

Dietary Supplement: entral feeding

Interventions

entral feeding DIETARY_SUPPLEMENT

Intermittent enteral feeding group recieved intermittent feeding as the feed was given over a 24 hour period with intervals of rest (e.g. three hours feeding two hours rest)

, feeding bag group; intermittent entral feeding group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age of 18 - 60 years.
• patients of both genders.
• patients with a functional gastrointestinal tract and poor oral nutritional intake.

You may not qualify if:

• patients for whom par-enteral nutrition would be more suitable.
• patients wit GIT obstruction or fistula.
• patients with ischemic bowel.
• patients in whom enteral feeding access is not available

Sponsors & Collaborators

• Sarah Asmaa: lead

Study Sites (1)

Faculty of Nursing

Asyut, Egypt

Location

Study Officials

• Amal A Mohamed

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asmaa Al Mahgoub, A professor

CONTACT

01016338015; Asmaa_sara16@yahoo.com

Ahmea T Ahmed, lecture

CONTACT

01062716629; talaat83@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: clinical professor

Model Details: After getting ethical clearance; patients were enrolled in the study, patients were selected based on the inclusion and exclusion criteria. Following an initial assessment, the patients were assigned to one of the two groups by block randomization. Both groups received 3000 ml of feed per day and the same formula per day which was 30-35ml/kg of water, 0.8 g/kg of protein and 2000 kcal of calories for females and 2500 Kcal for males. The only manipulation was in the flow rate and the device which the feed was administred.

Study Record Dates

• First Submitted: August 29, 2020
• First Posted: October 6, 2020
• Study Start: September 30, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 30, 2020
• Last Updated: October 6, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)