Effect of Non-nutritive Sucking on Feeding Intolerance

NCT06065839 | Recruiting

• 1 other identifier: 202201089A3
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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

Non-nutritive Sucking

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Control group

NO INTERVENTION

non-nutritive sucking was not given before feeding

Experimental group A

ACTIVE COMPARATOR

Give pacifier non-nutritive sucking for 5 minutes before feeding

Other: non-nutritive sucking 5 minutes

Experimental group B

PLACEBO COMPARATOR

Give pacifier non-nutritive sucking for 15 minutes before feeding

Other: non-nutritive sucking 15 minutes

Interventions

non-nutritive sucking 5 minutes OTHER

Give pacifier non-nutritive sucking for 5 minutes before feeding

Experimental group A

non-nutritive sucking 15 minutes OTHER

Give pacifier non-nutritive sucking for 15 minutes before feeding

Experimental group B

Eligibility Criteria

• Age: 26 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Kwei-Shan District, 333, Taiwan

RECRUITING

Related Publications (5)

• 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.

  PMID: 6401358 BACKGROUND

• 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.

  PMID: 4020566 BACKGROUND

• 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.

  PMID: 27699765 RESULT

• 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.

  PMID: 2888258 RESULT

• 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.

  PMID: 2899621 RESULT

Study Officials

• Yu-Ting HUANG, BSN

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Shi-Fang TSENG, BSN

  Chang Gung Memorial Hospital

  STUDY CHAIR

• Jian-Tao LEE, PhD

  Chang Gung University

  STUDY DIRECTOR

Central Study Contacts

Yu-Ting HUANG, BSN

CONTACT

+886975832680; Bunny@cgmh.org.tw

Yu-Ting HUANG, BSN

CONTACT

+88633281200

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chang Gung Memorial Hospital

Study Record Dates

• First Submitted: September 3, 2023
• First Posted: October 4, 2023
• Study Start: September 20, 2022
• Primary Completion: August 16, 2024
• Study Completion: August 16, 2024
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)