Non-nutritive SuckingNCT06065839
Effect of Non-nutritive Sucking on Feeding Intolerance
A study testing non-nutritive sucking 5 minutes and non-nutritive sucking 15 minutes in people with Non-nutritive Sucking, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 26 to 32 weeksHealthy volunteers can take part
- Conditions the study is for
- Non-nutritive Sucking
- What is being tested?
- non-nutritive sucking 5 minutes and non-nutritive sucking 15 minutes
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Sep 2022to 16 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 32 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Severe hypoxemia
- Severe hypotension
- Esophageal perforation
- Necrotic enteritis
- Infection-induced sepsis
- 3-4 grades of ventricular hemorrhage
Trial locations and contacts
1 site in 1 country.
Yu-Ting HUANG, BSN contact
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan, Kwei-Shan District, 333
Yu-Ting HUANG, BSN, +88633281200 ext. 8626, Bunny@cgmh.org.tw
About this study
Official title: 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.
- Conditions
- Non-nutritive Sucking
- Being tested
- non-nutritive sucking 5 minutes, non-nutritive sucking 15 minutes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-nutritive sucking 5 minutesOther
Give pacifier non-nutritive sucking for 5 minutes before feeding
non-nutritive sucking 15 minutesOther
Give pacifier non-nutritive sucking for 15 minutes before feeding
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: non-nutritive sucking 5 minutes |
| Experimental group B | Placebo comparator | Give pacifier non-nutritive sucking for 15 minutes before feeding Receives: Other: non-nutritive sucking 15 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
feeding intolerance
Gastric residual volume in milliliter
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start20 Sep 2022
- Primary completion16 Aug 2024 (estimated)
- Study completion16 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Non-nutritive SuckingStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HUANG, YU-TING, Chang Gung Memorial Hospital
- Investigators
- Yu-Ting HUANG, BSN, Principal investigator, Chang Gung Memorial HospitalShi-Fang TSENG, BSN, Study chair, Chang Gung Memorial HospitalJian-Tao LEE, PhD, Study director, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065839
- Sponsor's protocol ID
- 202201089A3
- Status last verified
- Aug 2024
- First submitted
- 3 Sep 2023
- Last updated
- 19 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 6401358Szabo 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.
PubMed 4020566Foster 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.
PubMed 27699765Marchini 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.
PubMed 2888258Widstrom 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.
PubMed 2899621
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-nutritive Sucking on Feeding Intolerance in Premature Infants
- ClinicalTrials.gov ID
- NCT06065839
- Acronym / sponsor ID
- 202201089A3
- Conditions
- Non-nutritive Sucking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 16 Aug 2024 (estimated)
- Study completion
- 16 Aug 2024 (estimated)
- First posted
- 4 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –non-nutritive sucking was not given before feeding |
| Experimental group A | Active comparator | Other: non-nutritive sucking 5 minutesGive pacifier non-nutritive sucking for 5 minutes before feeding |
| Experimental group B | Placebo comparator | Other: non-nutritive sucking 15 minutesGive pacifier non-nutritive sucking for 15 minutes before feeding |
Who may qualify
- Ages
- 26 to 32 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- Severe hypoxemia
- Severe hypotension
- Esophageal perforation
- Necrotic enteritis
- Infection-induced sepsis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-nutritive sucking 5 minutesGive pacifier non-nutritive sucking for 5 minutes before feeding | Other | Experimental group A |
| non-nutritive sucking 15 minutesGive pacifier non-nutritive sucking for 15 minutes before feeding | Other | Experimental group B |
Primary outcome
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Background: PubMed 6401358Bernbaum 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.
- Background: PubMed 4020566Szabo 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.
- Results publication: PubMed 27699765Foster 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.
- Results publication: PubMed 2888258Marchini 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.
- Results publication: PubMed 2899621Widstrom 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.
- Individual participant dataSharing planned: No
Related trials for Non-nutritive Sucking
Not yet recruiting
Effects of a Pacifier on Obstructive Sleep Apnea and Its Repercussions in Infants With Down Syndrome
Obstructive Sleep Apnea, Down Syndrome (Trisomy 21)
RecruitingObservational study
Oro-myofunctional Characteristics and Obstructive Sleep Apnea in Infants With Down Syndrome
Obstructive Sleep Apnea, Down Syndrome (Trisomy 21)
Not yet recruiting
Premature Infant Oral Motor Intervention vs. Pacifier for Oral Feeding Transition in Preterm Infants
Feeding Difficulties, Sucking Behavior
Recruiting
Feeding Maturity in Preterm Infants
Preterm, Feeding
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Ting HUANG, BSN contact
Yu-Ting HUANG, BSN principal investigator
Chang Gung Memorial Hospital
Shi-Fang TSENG, BSN study chair
Chang Gung Memorial Hospital
Jian-Tao LEE, PhD study director
Chang Gung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-nutritive sucking 5 minutes and non-nutritive sucking 15 minutes in people with Non-nutritive Sucking, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Ting HUANG, BSN (+886975832680, Bunny@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06065839, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.