Actively Recruiting

Phase Not Applicable
Age: 26Weeks - 32Weeks
All Genders
Healthy Volunteers
NCT06065839

Effect of Non-nutritive Sucking on Feeding Intolerance

Led by Chang Gung Memorial Hospital · Updated on 2024-08-19

180

Participants Needed

1

Research Sites

99 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The design of this study is an experimental research design, and the research subjects who meet the conditions of acceptance will be used as randomized controlled trials. Cases meeting the sampling conditions in the neonatal intensive care unit were stratified according to birth weeks (26 to 27+6 weeks and 28 to 31+6 weeks), and then randomly assigned to experimental group A (non-nutritive sucking 5 minutes), experimental group B (non-nutritive sucking for 15 minutes) and control group (no non-nutritive sucking). The variables controlled in this study were gestational weeks, birth weight, sex, Apgar score, respirator use, and type of milk fed. The premature infants in the experimental group were given non-nutritive sucking before the first tube-feeding and the feeding volume reached 10mL/kg/day, while the control group was not given non-nutritive sucking before tube-feeding. The interventional measures adopted in this study were set as two meals a day before 17:00, and the patients were force-fed every three hours, and the time interval between the two interventional measures was every six hours (intervention measures were provided every other meal) , the measurement time, times and intervals of the two groups are the same. Experimental group A was given pacifier NNS 5 minutes before each feeding, experimental group B was given pacifier NNS 15 minutes before each feeding, while the control group was not given NNS before feeding, and the two groups were given 150 minutes after feeding (ie 30 minutes before the next force-feeding) to monitor gastric residual volume, changes in abdominal circumference, and vomiting. Since FI mainly occurred 48-72 hours after the start of feeding, the duration of this study was 3 consecutive days to compare with the control group. The acceptance conditions of the research objects are: 1. Premature infants whose gestational age is more than 26 weeks (inclusive) to less than 32 weeks, 2. Premature neonates who have been placed with orogastric tube or nasogastric tube for force-feeding, 3. No congenital gastrointestinal tract Abnormal, 4. No serious congenital abnormalities and heart disease, no cleft lip and palate, 5. Never received stomach or intestinal surgery, 6. No central nervous system damage, 7. With the consent of their parents or guardians, and fill out the consent form By. If the condition is unstable during the course of the case, including severe hypoxemia, hypotension, esophageal perforation, necrotic enteritis, sepsis caused by infection, and grade 3-4 intraventricular hemorrhage, etc., they will be excluded.

CONDITIONS

Official Title

Effect of Non-nutritive Sucking on Feeding Intolerance

Who Can Participate

Age: 26Weeks - 32Weeks
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Premature infants whose gestational age is more than 26 weeks (inclusive) to less than 32 weeks
  • Premature neonates who are force-fed with orogastric or nasogastric tubes
  • No congenital gastrointestinal abnormalities
  • No serious Congenital anomalies and heart disease, no cleft lip and palate
  • Never received stomach or intestinal surgery
  • No central nervous system damage
  • With the consent of their parents or guardians, and fill out the consent form.
Not Eligible

You will not qualify if you...

  • Severe hypoxemia
  • Severe hypotension
  • Esophageal perforation
  • Necrotic enteritis
  • Infection-induced sepsis
  • 3-4 grades of ventricular hemorrhage

AI-Screening

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Trial Site Locations

Total: 1 location

1

Chang Gung Memorial Hospital

Taoyuan, Kwei-Shan District, Taiwan, 333

Actively Recruiting

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Research Team

Y

Yu-Ting HUANG, BSN

CONTACT

Y

Yu-Ting HUANG, BSN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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Effect of Non-nutritive Sucking on Feeding Intolerance | DecenTrialz