Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
180 participants
INTERVENTIONAL
2022-09-20
2024-08-16
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Control group
non-nutritive sucking was not given before feeding
No interventions assigned to this group
Experimental group A
Give pacifier non-nutritive sucking for 5 minutes before feeding
non-nutritive sucking 5 minutes
Give pacifier non-nutritive sucking for 5 minutes before feeding
Experimental group B
Give pacifier non-nutritive sucking for 15 minutes before feeding
non-nutritive sucking 15 minutes
Give pacifier non-nutritive sucking for 15 minutes before feeding
Interventions
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non-nutritive sucking 5 minutes
Give pacifier non-nutritive sucking for 5 minutes before feeding
non-nutritive sucking 15 minutes
Give pacifier non-nutritive sucking for 15 minutes before feeding
Eligibility Criteria
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Inclusion Criteria
* 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 hypotension
* Esophageal perforation
* Necrotic enteritis
* Infection-induced sepsis
* 3-4 grades of ventricular hemorrhage
26 Weeks
32 Weeks
ALL
Yes
Sponsors
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Chang Gung Memorial Hospital
OTHER
Responsible Party
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HUANG, YU-TING
Chang Gung Memorial Hospital
Principal Investigators
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Yu-Ting HUANG, BSN
Role: PRINCIPAL_INVESTIGATOR
Chang Gung Memorial Hospital
Shi-Fang TSENG, BSN
Role: STUDY_CHAIR
Chang Gung Memorial Hospital
Jian-Tao LEE, PhD
Role: STUDY_DIRECTOR
Chang Gung University
Locations
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Chang Gung Memorial Hospital
Taoyuan District, Kwei-Shan District, Taiwan
Countries
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Central Contacts
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Yu-Ting HUANG, BSN
Role: CONTACT
Facility Contacts
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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202201089A3
Identifier Type: -
Identifier Source: org_study_id
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