Effect of Non-nutritive Sucking on Feeding Intolerance

Effect of Non-nutritive Sucking on Feeding Intolerance in Premature Infants

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.

Study Overview

• Status: Recruiting
• Conditions: Non-nutritive Sucking
• Intervention / Treatment: Other: non-nutritive sucking 5 minutes; Other: non-nutritive sucking 15 minutes

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yu-Ting HUANG, BSN; Phone Number: +886975832680; Email: Bunny@cgmh.org.tw
• Study Contact Backup: Name: Yu-Ting HUANG, BSN; Phone Number: 8626 +88633281200

Study Locations

• Taiwan
  • Kwei-Shan District
    • Taoyuan, Kwei-Shan District, Taiwan, 333
      • Recruiting
      • Chang Gung Memorial Hospital
      • Contact: Yu-Ting HUANG, BSN; Phone Number: 8626 +88633281200; Email: Bunny@cgmh.org.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; non-nutritive sucking was not given before feeding
Active Comparator: Experimental group A; Give pacifier non-nutritive sucking for 5 minutes before feeding	Other: non-nutritive sucking 5 minutes; Give pacifier non-nutritive sucking for 5 minutes before feeding
Placebo Comparator: Experimental group B; Give pacifier non-nutritive sucking for 15 minutes before feeding	Other: non-nutritive sucking 15 minutes; Give pacifier non-nutritive sucking for 15 minutes before feeding

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
feeding intolerance	Gastric residual volume in milliliter	The test was carried out twice a day, with an interval of 6 hours between each data collection, and the test was carried out continuously for 3 days
feeding intolerance	abdominal circumference in centimeter	The test was carried out twice a day, with an interval of 6 hours between each data collection, and the test was carried out continuously for 3 days
feeding intolerance	vomiting in frequency	The test was carried out twice a day, with an interval of 6 hours between each data collection, and the test was carried out continuously for 3 days

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Yu-Ting HUANG, BSN, Chang Gung Memorial Hospital; Study Chair: Shi-Fang TSENG, BSN, Chang Gung Memorial Hospital; Study Director: Jian-Tao LEE, PhD, Chang Gung University

Publications and helpful links

General Publications

• Foster JP, Psaila K, Patterson T. Non-nutritive sucking for increasing physiologic stability and nutrition in preterm infants. Cochrane Database Syst Rev. 2016 Oct 4;10(10):CD001071. doi: 10.1002/14651858.CD001071.pub3.
• Bernbaum JC, Pereira GR, Watkins JB, Peckham GJ. Nonnutritive sucking during gavage feeding enhances growth and maturation in premature infants. Pediatrics. 1983 Jan;71(1):41-5.
• Szabo JS, Hillemeier AC, Oh W. Effect of non-nutritive and nutritive suck on gastric emptying in premature infants. J Pediatr Gastroenterol Nutr. 1985 Jun;4(3):348-51. doi: 10.1097/00005176-198506000-00004.
• Marchini G, Lagercrantz H, Feuerberg Y, Winberg J, Uvnas-Moberg K. The effect of non-nutritive sucking on plasma insulin, gastrin, and somatostatin levels in infants. Acta Paediatr Scand. 1987 Jul;76(4):573-8. doi: 10.1111/j.1651-2227.1987.tb10523.x.
• Widstrom AM, Marchini G, Matthiesen AS, Werner S, Winberg J, Uvnas-Moberg K. Nonnutritive sucking in tube-fed preterm infants: effects on gastric motility and gastric contents of somatostatin. J Pediatr Gastroenterol Nutr. 1988 Jul-Aug;7(4):517-23. doi: 10.1097/00005176-198807000-00007.

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2022
• Primary Completion (Estimated): August 16, 2024
• Study Completion (Estimated): August 16, 2024

Study Registration Dates

• First Submitted: September 3, 2023
• First Submitted That Met QC Criteria: October 1, 2023
• First Posted (Actual): October 4, 2023

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: August 16, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 202201089A3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No