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NCT Number: NCT06065839

Effect of Non-nutritive Sucking on Feeding Intolerance

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.

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Key information

Age range

26 week–32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital

Taoyuan, Kwei-Shan District, 333, Taiwan

Location status: Recruiting

Location contact

Yu-Ting HUANG, BSN

CONTACT

[email protected]

+88633281200 ext. 8626

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

non-nutritive sucking 5 minutes

Other

Give pacifier non-nutritive sucking for 5 minutes before feeding

non-nutritive sucking 15 minutes

Other

Give pacifier non-nutritive sucking for 15 minutes before feeding

Primary outcomes

  1. feeding intolerance

    Time frame: 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

    Gastric residual volume in milliliter

  2. feeding intolerance

    Time frame: 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

    abdominal circumference in centimeter

  3. feeding intolerance

    Time frame: 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

    vomiting in frequency

Study contacts

Contact information is provided by the study sponsor or research team.

Yu-Ting HUANG, BSN

CONTACT

[email protected]

+886975832680

Yu-Ting HUANG, BSN

CONTACT

+88633281200 ext. 8626

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 4, 2023
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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