Preterm InfantNCT03755999
A Cue-based Developmental Approach Toward the Preterm Infants During Feeding Transition Period
A study testing The premature infant oral motor intervention (PIOMI) in people with Preterm Infant and Feeding Behavior, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
The coordination of sucking, swallowing, and breathing during the transition from gavage to oral feeding is a challenge for preterm infants. Efficient management of the feeding transition without other comorbidities can not only improve their oral movements and gastrointestinal function development, facilitate their… Read more about this study
- Who is it for?
- Ages Up to 33 weeks
- Conditions the study is for
- Preterm Infant, Feeding Behavior, Feeding Patterns
- What is being tested?
- The premature infant oral motor intervention (PIOMI)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2018to 31 Jul 2023
- 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 Up to 33 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infant born less then 33 weeks
- Fraction of inspired oxygen(FiO2) less then 30%
- Can tolerance enteral feeding
Who cannot join
- Using ventilator(except non-invasive ventilator)
- Complications including Hypoxic Ischemic Encephalopathy (HIE), Intraventricular Hemorrhage (IVH) ≥Grade III, Periventricular Leukomalacia (PVL), Necrotizing Enterocolitis(NEC) ≥Stage II
- Congenital abnormalities including chromosomal abnormalities, congenital anomalies of digestive system, cleft lip and palate
- Because of custody problem or can't get the inform consent of the preterm infant's parents/guardian
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cue-based Developmental Approach Toward the Preterm Infants During Feeding Transition Period - Explore Clinical Facts, Evaluate Intervention Effects and Develop Clinical Guideline
The coordination of sucking, swallowing, and breathing during the transition from gavage to oral feeding is a challenge for preterm infants. Efficient management of the feeding transition without other comorbidities can not only improve their oral movements and gastrointestinal function development, facilitate their oral feeding learning behavior, but also facilitate them to direct breastfeeding, improve mother-infant attachment, and ultimately reduce the length of hospitalization. However, the current status of strategies in supporting preterm infants throughout their feeding transition are inconsistent, and lack of guidelines and monitor indicators based on existing evidence.
This project proposed a three-year plan the explore the current situation, examine effective strategies for care bundles, and further develop a new clinical guideline that can be implemented in the future. The first year of this research will use chart review among two neonatal intensive care units of Medical Center from Taipei and Tainan. A semi-structured interview and questionnaire (DSCS-N) will be used to explore nurses' knowledge, attitude and skills of developmental care; and the experience of caring for preterm infants during feeding transition in the neonatal intensive care units. In addition, gestational age, body weight, gavage and oral feeding amount, and special events happened during feeding will be recorded and analyzed.
Read more
The second year, an experimental with a stratified random assignment and repeated measure design will be used with feeding transition care bundles. 120 preterm infants will be recruited and assigned to experimental or control group. The subjects will be fed by the routine care approach or by the feeding transition approach in one neonatal intensive care unit. Intervention components include oral stimulation and cue-based feeding during the transition to oral feeding. Study measures will include physical indicators, POFRAS and EFS during feeding to evaluate the implementation and guide further development of the clinical guideline.
The third year of guideline development will follow Bowker and the National Health Insurance Bureau which including 5 stage. The results of this guideline can offer better recommendations to support preterm infants' oral development, provide cue-based feeding, and help them succeed in the transition to oral nutrition.
- Conditions
- Preterm Infant, Feeding Behavior, Feeding Patterns
- Being tested
- The premature infant oral motor intervention (PIOMI)
- Keywords
- preterm infants, transitional feeding period, cue-based care, clinical guidelines
- Medical subject headings
- Premature Birth, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The premature infant oral motor intervention (PIOMI)Other
Also called Cue-based feeding
The premature infant oral motor intervention (PIOMI) is an oral motor program that provides assisted movement to activate muscle contraction and provides movement against resistance to build strength in the areas of the mouth necessary for feeding. It is designed to increase the maturation of neural structures, improving their ability to suck and swallow.
| Study group | Role | What they receive |
|---|---|---|
| PIOMI treat group | Experimental | Preterm infant receive oral massage using the premature infant oral motor intervention (PIOMI) Receives: Other: The premature infant oral motor intervention (PIOMI) |
| Routine care group | No intervention | Preterm infant receive routine care of neonatal intensive care unit(NICU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preterm infant's oral feeding readiness
We use the Preterm Oral Feeding Readiness Assessment Scales (POFRAS) to assess preterm infants' readiness to start oral feeding. The scale comprised of 5 five categories including corrected Gestational Age, Behavioral Organization (3 item), Oral Posture (2 item), Oral Reflexes (4 item), Nonnutritive Sucking (8 item) with a total of 18 items to evaluate. Each item score from 0~2, the higher the score means that the preterm infant has better oral feeding preparation.
Measured: Change from day 1(Baseline) up to day 7 in oral stimulation phase
Preterm infant's oral feeding skills
Using Early Feeding Skills Assessments for Preterm Infants (EFS). The Early Feeding Skills Assessments for Preterm Infants (EFS) checklist is to assess preterm infants' oral feeding readiness (before feeding; yes/no), oral feeding skill (when feeding; all/most/some/none; never/occasionally/often), oral feeding tolerance (after feeding; yes/no) and feeding descriptors(after feeding).
Measured: From day 1(Baseline) up to the day 30 in cue-base feeding phase
Secondary outcomes (2)
Body weight change
body weight change in grams
Measured: Change from day 1(baseline) up to the day 200.
hospital stay length(days)
How many days from admission(birth day) to discharge(leave) hospital.
Measured: From day 1 up to the day 200.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start1 Nov 2018
- Primary completion31 Jul 2020
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (50)Papers the sponsor has linked to this study.
- Other trials for Preterm InfantStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan, National Taiwan University Hospital
- Responsible party
- Sponsor
- Investigators
- Mei-Chih Huang, Principal investigator, Department of Nursing, College of Medicine, National Cheng-Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03755999
- Sponsor's protocol ID
- MOST 107-2314-B-006-009-MY3
- Status last verified
- Jul 2022
- First submitted
- 22 Aug 2018
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aita M, Snider L. The art of developmental care in the NICU: a concept analysis. J Adv Nurs. 2003 Feb;41(3):223-32. doi: 10.1046/j.1365-2648.2003.02526.x.
PubMed 12581110Als H. Toward a synactive theory of development: Promise for the assessment and support of infant individuality. Infant Mental Health Journal 3(4): 229-243, 1982.
Als H, Butler S, Kosta S, McAnulty G. The Assessment of Preterm Infants' Behavior (APIB): furthering the understanding and measurement of neurodevelopmental competence in preterm and full-term infants. Ment Retard Dev Disabil Res Rev. 2005;11(1):94-102. doi: 10.1002/mrdd.20053.
PubMed 15856436Bala P, Kaur R, Mukhopadhyay K, Kaur S. Oromotor Stimulation for Transition from Gavage to Full Oral Feeding in Preterm Neonates: A Randomized controlled trial. Indian Pediatr. 2016 Jan;53(1):36-8. doi: 10.1007/s13312-016-0786-3.
PubMed 26840669Balshem H, Helfand M, Schunemann HJ, Oxman AD, Kunz R, Brozek J, Vist GE, Falck-Ytter Y, Meerpohl J, Norris S, Guyatt GH. GRADE guidelines: 3. Rating the quality of evidence. J Clin Epidemiol. 2011 Apr;64(4):401-6. doi: 10.1016/j.jclinepi.2010.07.015. Epub 2011 Jan 5.
PubMed 21208779Bolzan Gde P, Berwig LC, Prade LS, Cuti LK, Yamamoto RC, Silva AM, Weinmann AR. Assessment for oral feeding in preterm infants. Codas. 2016 Jul 4;0:0. doi: 10.1590/2317-1782/20162015115. English, Portuguese.
PubMed 27383226Brouwers MC, Kho ME, Browman GP, Burgers JS, Cluzeau F, Feder G, Fervers B, Graham ID, Grimshaw J, Hanna SE, Littlejohns P, Makarski J, Zitzelsberger L; AGREE Next Steps Consortium. AGREE II: advancing guideline development, reporting and evaluation in health care. CMAJ. 2010 Dec 14;182(18):E839-42. doi: 10.1503/cmaj.090449. Epub 2010 Jul 5. No abstract available.
PubMed 20603348Byers JF. Components of developmental care and the evidence for their use in the NICU. MCN Am J Matern Child Nurs. 2003 May-Jun;28(3):174-80; quiz 181-2. doi: 10.1097/00005721-200305000-00007.
PubMed 12771696Fujinaga CI, Zamberlan NE, Rodarte MD, Scochi CG. [Reliability of an instrument to assess the readiness of preterm infants for oral feeding]. Pro Fono. 2007 Apr-Jun;19(2):143-50. doi: 10.1590/s0104-56872007000200002. Portuguese.
PubMed 17710340da Costa SP, van der Schans CP. The reliability of the Neonatal Oral-Motor Assessment Scale. Acta Paediatr. 2008 Jan;97(1):21-6. doi: 10.1111/j.1651-2227.2007.00577.x.
PubMed 18201309da Costa SP, Hubl N, Kaufman N, Bos AF. New scoring system improves inter-rater reliability of the Neonatal Oral-Motor Assessment Scale. Acta Paediatr. 2016 Aug;105(8):e339-44. doi: 10.1111/apa.13461. Epub 2016 Jun 6.
PubMed 27164051Fucile S, Gisel EG, Lau C. Effect of an oral stimulation program on sucking skill maturation of preterm infants. Dev Med Child Neurol. 2005 Mar;47(3):158-62. doi: 10.1017/s0012162205000290.
PubMed 15739719Fucile S, Gisel E, Lau C. Oral stimulation accelerates the transition from tube to oral feeding in preterm infants. J Pediatr. 2002 Aug;141(2):230-6. doi: 10.1067/mpd.2002.125731.
PubMed 12183719Fujinaga CI, de Moraes SA, Zamberlan-Amorim NE, Castral TC, de Almeida e Silva A, Scochi CG. Clinical validation of the Preterm Oral Feeding Readiness Assessment Scale. Rev Lat Am Enfermagem. 2013 Jan-Feb;21 Spec No:140-5. doi: 10.1590/s0104-11692013000700018. English, Portuguese.
PubMed 23459901Gennattasio A, Perri EA, Baranek D, Rohan A. Oral feeding readiness assessment in premature infants. MCN Am J Matern Child Nurs. 2015 Mar-Apr;40(2):96-104; E9-10. doi: 10.1097/NMC.0000000000000115.
PubMed 25494013
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cue-based Developmental Approach Toward the Preterm Infants During Feeding Transition Period - Explore Clinical Facts, Evaluate Intervention Effects and Develop Clinical Guideline
- ClinicalTrials.gov ID
- NCT03755999
- Acronym / sponsor ID
- MOST 107-2314-B-006-009-MY3
- Conditions
- Preterm Infant, Feeding Behavior, Feeding Patterns
- Keywords
- preterm infants, transitional feeding period, cue-based care, clinical guidelines
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan, National Taiwan University Hospital
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 28 Nov 2018 (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 coordination of sucking, swallowing, and breathing during the transition from gavage to oral feeding is a challenge for preterm infants. Efficient management of the feeding transition without other comorbidities can not only improve their oral movements and gastrointestinal function development, facilitate their oral feeding learning behavior, but also facilitate them to direct breastfeeding, improve mother-infant attachment, and ultimately reduce the length of hospitalization. However, the current status of strategies in supporting preterm infants throughout their feeding transition are inconsistent, and lack of guidelines and monitor indicators based on existing evidence.
This project proposed a three-year plan the explore the current situation, examine effective strategies for care bundles, and further develop a new clinical guideline that can be implemented in the future. The first year of this research will use chart review among two neonatal intensive care units of Medical Center from Taipei and Tainan. A semi-structured interview and questionnaire (DSCS-N) will be used to explore nurses' knowledge, attitude and skills of developmental care; and the experience of caring for preterm infants during feeding transition in the neonatal intensive care units. In addition, gestational age, body weight, gavage and oral feeding amount, and special events happened during feeding will be recorded and analyzed.
The second year, an experimental with a stratified random assignment and repeated measure design will be used with feeding transition care bundles. 120 preterm infants will be recruited and assigned to experimental or control group. The subjects will be fed by the routine care approach or by the feeding transition approach in one neonatal intensive care unit. Intervention components include oral stimulation and cue-based feeding during the transition to oral feeding. Study measures will include physical indicators, POFRAS and EFS during feeding to evaluate the implementation and guide further development of the clinical guideline.
The third year of guideline development will follow Bowker and the National Health Insurance Bureau which including 5 stage. The results of this guideline can offer better recommendations to support preterm infants' oral development, provide cue-based feeding, and help them succeed in the transition to oral nutrition.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PIOMI treat group | Experimental | Other: The premature infant oral motor intervention (PIOMI)Preterm infant receive oral massage using the premature infant oral motor intervention (PIOMI) |
| Routine care group | No intervention | –Preterm infant receive routine care of neonatal intensive care unit(NICU) |
Who may qualify
- Ages
- Up to 33 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Preterm infant born less then 33 weeks
- Fraction of inspired oxygen(FiO2) less then 30%
- Can tolerance enteral feeding
Key exclusion criteria (4 listed)
- Using ventilator(except non-invasive ventilator)
- Complications including Hypoxic Ischemic Encephalopathy (HIE), Intraventricular Hemorrhage (IVH) ≥Grade III, Periventricular Leukomalacia (PVL), Necrotizing Enterocolitis(NEC) ≥Stage II
- Congenital abnormalities including chromosomal abnormalities, congenital anomalies of digestive system, cleft lip and palate
- Because of custody problem or can't get the inform consent of the preterm infant's parents/guardian
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 |
|---|---|---|
| The premature infant oral motor intervention (PIOMI)Also: Cue-based feedingThe premature infant oral motor intervention (PIOMI) is an oral motor program that provides assisted movement to activate muscle contraction and provides movement against resistance to build strength in the areas of the mouth necessary for feeding. It is designed to increase the maturation of neural structures, improving their ability to suck and swallow. | Other | PIOMI treat group |
Primary outcome
Preterm infant's oral feeding readiness
Time frame: Change from day 1(Baseline) up to day 7 in oral stimulation phase
We use the Preterm Oral Feeding Readiness Assessment Scales (POFRAS) to assess preterm infants' readiness to start oral feeding. The scale comprised of 5 five categories including corrected Gestational Age, Behavioral Organization (3 item), Oral Posture (2 item), Oral Reflexes (4 item), Nonnutritive Sucking (8 item) with a total of 18 items to evaluate. Each item score from 0~2, the higher the score means that the preterm infant has better oral feeding preparation.
Preterm infant's oral feeding skills
Time frame: From day 1(Baseline) up to the day 30 in cue-base feeding phase
Using Early Feeding Skills Assessments for Preterm Infants (EFS). The Early Feeding Skills Assessments for Preterm Infants (EFS) checklist is to assess preterm infants' oral feeding readiness (before feeding; yes/no), oral feeding skill (when feeding; all/most/some/none; never/occasionally/often), oral feeding tolerance (after feeding; yes/no) and feeding descriptors(after feeding).
2 secondary outcomes
Body weight change
Time frame: Change from day 1(baseline) up to the day 200.
hospital stay length(days)
Time frame: From day 1 up to the day 200.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- Background: PubMed 12581110Aita M, Snider L. The art of developmental care in the NICU: a concept analysis. J Adv Nurs. 2003 Feb;41(3):223-32. doi: 10.1046/j.1365-2648.2003.02526.x.
- BackgroundAls H. Toward a synactive theory of development: Promise for the assessment and support of infant individuality. Infant Mental Health Journal 3(4): 229-243, 1982.
- Background: PubMed 15856436Als H, Butler S, Kosta S, McAnulty G. The Assessment of Preterm Infants' Behavior (APIB): furthering the understanding and measurement of neurodevelopmental competence in preterm and full-term infants. Ment Retard Dev Disabil Res Rev. 2005;11(1):94-102. doi: 10.1002/mrdd.20053.
- Background: PubMed 26840669Bala P, Kaur R, Mukhopadhyay K, Kaur S. Oromotor Stimulation for Transition from Gavage to Full Oral Feeding in Preterm Neonates: A Randomized controlled trial. Indian Pediatr. 2016 Jan;53(1):36-8. doi: 10.1007/s13312-016-0786-3.
- Background: PubMed 21208779Balshem H, Helfand M, Schunemann HJ, Oxman AD, Kunz R, Brozek J, Vist GE, Falck-Ytter Y, Meerpohl J, Norris S, Guyatt GH. GRADE guidelines: 3. Rating the quality of evidence. J Clin Epidemiol. 2011 Apr;64(4):401-6. doi: 10.1016/j.jclinepi.2010.07.015. Epub 2011 Jan 5.
- Background: PubMed 27383226Bolzan Gde P, Berwig LC, Prade LS, Cuti LK, Yamamoto RC, Silva AM, Weinmann AR. Assessment for oral feeding in preterm infants. Codas. 2016 Jul 4;0:0. doi: 10.1590/2317-1782/20162015115. English, Portuguese.
- Background: PubMed 20603348Brouwers MC, Kho ME, Browman GP, Burgers JS, Cluzeau F, Feder G, Fervers B, Graham ID, Grimshaw J, Hanna SE, Littlejohns P, Makarski J, Zitzelsberger L; AGREE Next Steps Consortium. AGREE II: advancing guideline development, reporting and evaluation in health care. CMAJ. 2010 Dec 14;182(18):E839-42. doi: 10.1503/cmaj.090449. Epub 2010 Jul 5. No abstract available.
- Background: PubMed 12771696Byers JF. Components of developmental care and the evidence for their use in the NICU. MCN Am J Matern Child Nurs. 2003 May-Jun;28(3):174-80; quiz 181-2. doi: 10.1097/00005721-200305000-00007.
- Background: PubMed 17710340Fujinaga CI, Zamberlan NE, Rodarte MD, Scochi CG. [Reliability of an instrument to assess the readiness of preterm infants for oral feeding]. Pro Fono. 2007 Apr-Jun;19(2):143-50. doi: 10.1590/s0104-56872007000200002. Portuguese.
- Background: PubMed 18201309da Costa SP, van der Schans CP. The reliability of the Neonatal Oral-Motor Assessment Scale. Acta Paediatr. 2008 Jan;97(1):21-6. doi: 10.1111/j.1651-2227.2007.00577.x.
- Background: PubMed 27164051da Costa SP, Hubl N, Kaufman N, Bos AF. New scoring system improves inter-rater reliability of the Neonatal Oral-Motor Assessment Scale. Acta Paediatr. 2016 Aug;105(8):e339-44. doi: 10.1111/apa.13461. Epub 2016 Jun 6.
- Background: PubMed 15739719Fucile S, Gisel EG, Lau C. Effect of an oral stimulation program on sucking skill maturation of preterm infants. Dev Med Child Neurol. 2005 Mar;47(3):158-62. doi: 10.1017/s0012162205000290.
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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.
Mei-Chih Huang principal investigator
Department of Nursing, College of Medicine, National Cheng-Kung 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 The premature infant oral motor intervention (PIOMI) in people with Preterm Infant and Feeding Behavior, run by National Cheng-Kung University 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 3 inclusion and 4 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 30 Sep 2022. 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preterm infant's oral feeding readiness (time frame: Change from day 1(Baseline) up to day 7 in oral stimulation phase). The study lists 2 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 NCT03755999, which also lists 50 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 30 Sep 2022.