DysphagiaPIOMINCT06395298
Effects of the Application of PIOMI in the Oral Feeding of Premature
A study testing Experimental group PIOMI in people with Dysphagia and Disorder; Feeding, Newborn, run by Fundació Sant Joan de Déu at 1 site in Spain.
Trial summary
The goal of this clinical trial is assess whether the application of the premature oral motor intervention (PIOMI) combined with the Newborn Individualized Developmental Care and Assessment Program (NIDCAP), allows withdrawal of the external feeding device with guarantees of the patient's nutritional status… Read more about this study
- Who is it for?
- Ages 29 to 30 weeks
- Conditions the study is for
- Dysphagia, Disorder; Feeding, Newborn, Premature
- What is being tested?
- Experimental group PIOMI
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteSpain
- Study dates
- 13 Feb 2023to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 29 to 30 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates born at the Sant Joan de Déu Hospital with a gestational age between 29-30 weeks carrying an external feeding device due to the difficulty of oral feeding and that the medical team in charge considers clinically stable.
Who cannot join
- Endotracheal intubation or high-flow ventilatory support.
- Exclusive parenteral nutrition.
- Hyporeactive due to the use of sedative drugs.
- Condition of prematurity associated with other pathologies (syndromes, acquired brain damage, gastrointestinal malformations, airway and craniofacial malformations).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Raquel García Ezquerra
Barcelona, Catalonia, 08096
Raquel García Ezquerra, raquel.garciae@sjd.es
Vanesa Ejarque Marin, vanesaem35.vem@gmail.com
About this study
Official title: Effects of the Application of PIOMI (Premature Oral Motor Intervention) in the Oral Feeding of the Premature: Randomized Clinical Trial
The goal of this clinical trial is assess whether the application of the premature oral motor intervention (PIOMI) combined with the Newborn Individualized Developmental Care and Assessment Program (NIDCAP), allows withdrawal of the external feeding device with guarantees of the patient's nutritional status, determining breastfeeding rates at hospital discharge and swallowing safety earlier than if only the care activity corresponding to the NIDCAP model is carried out, as well as the applicability of this standardised protocol in the neonatal intensive care unit of a tertiary hospital.
Read the detailed description
Prematurity is one of the most common factors affecting the development of oromotor skills, interfering with feeding. The most common clinical manifestation is uncoordinated sucking-breathing-swallowing cycle.
The incidence of oropharyngeal dysphagia in paediatrics is estimated at 10.40%, doubling in preterm infants weighing less than 1500 grams. The aetiological distribution of swallowing disorders in the neonatal age is highly variable, as is their clinical presentation. Current literature reflects the impact of the use of an external feeding device on the quality of life of the patient-family, as well as the increased health care costs due to prolonged hospitalisation, emergencies for device removal, consumables and enteral nutrition.
Current health models are based on prevention, hence the importance of establishing early protocols for assessment, diagnosis and intervention. The main difficulty in neonatal intensive care units is the loss of opportunity for oral feeding and the absence of standardised protocols, as there is great controversy regarding the intervention techniques that should be applied to promote the development of oral-motor skills.The PIOMI is the intervention model that currently presents the greatest scientific production, the results obtained in the studies carried out show a high success rate in relation to the initiation of oral feeding in preterm infants, as well as the maintenance of high breastfeeding rates at the time of hospital discharge and at 10 days, in compliance with the standards of the World Health Organisation (WHO).
At present, there are study designs of PIOMI, combined with olfactory-gustatory stimulation, but the latter is not specified as an oropharyngeal colostrum technique, which is currently indicated in the therapeutic guidelines, nor is the protocolised nursing care model described, an aspect that is of great importance because each hospital centre offers different care depending on whether or not the model is based on the individualised assessment and care programme for the development of the newborn.
This research aims to evaluate these aspects by means of a randomised double-blind parallel allocation clinical trial using Oxford Minimization and Randomization (OxMaR) software, to be carried out at the Hospital Sant Joan de Déu in Barcelona, in the neonatal intensive care unit in the period November 2023-2026. The sample size is n=35 preterm infants of gestational age 29-30+6.
The control group will follow the NIDCAP care model and the experimental group will apply the PIOMI+NIDCAP protocol for 5 minutes twice a day for 10 days, with olfactory stimulation and oropharyngeal colostrum for both groups.
The family will apply the intervention by accessing a quick response code with an information capsule according to the assigned group.
To identify factors, sociodemographic and health variables, process variables and outcome variables will be selected using the Neonatal Oral-motor Assessment Scale (NOMAS), Early Feeding Skills Assessment (EFSA) and pre- and post-tests will be analysed using variance analysis program (ANOVA) and statistical package for the social sciences (SPSS)
- Conditions
- Dysphagia, Disorder; Feeding, Newborn, Premature
- Being tested
- Experimental group PIOMI, Control group NIDCAP
- Keywords
- Swallowing, Swallowing disorders, Nutritional support, Feeding disorders, Preterm, Neonates, Sucking Behavior
- Medical subject headings
- Deglutition Disorders, Premature Birth, Feeding and Eating Disorders, Sucking Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental group PIOMIOther
Also called PIOMI+NIDCAP
A group treated with the application of the care model Newborn Individualized Development Care and Assessment Program (NIDCAP) in the Neonatal Intensive Unit Care (NICU)+PIOMI
Control group NIDCAPOther
Also called NIDCAP
A group treated with the application of the care model Newborn Individualized Development Care and Assessment Program (NIDCAP) in the Neonatal Intensive Unit Care (NICU)
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group PIOMI | Experimental | Participants will receive:
1. The traditional intervention Newborn Individualized Development Care and Assessment Program (NIDCAP) model of the Neonatal Intensive Care Unit (NICU) .The nurse providing direct care to the patient and family, will carry out the relevant care of the patient.
2. The Premature Oral Motor Intervention (PIOMI) .The family will apply the PIOMI , 7 activities are intraoral stimulation for 10 consecutive days, twice a day, 5 minutes.
3. Gustatory stimulation technique:the application of oropharyngeal colostrum, a 0.5 milliliter twice a day
4. Olfactory stimulation Technique:A swab is moistened in breast milk and placed near the nose for one minute, twice a day. Receives: Other: Experimental group PIOMI |
| Control Group NIDCAP | Sham comparator | Participants will receive :
1.The traditional intervention Newborn Individualized Development Care and Assessment Program (NIDCAP) model of the Neonatal Intensive Care Unit (NICU).The nurse providing direct care to the patient and family, will carry out the relevant care of the patient.
3.Gustatory stimulation technique:the application of oropharyngeal colostrum, a 0.5 milliliter twice a day
4.Olfactory stimulation Technique:A swab is moistened in breast milk and placed near the nose for one minute, twice a day. Receives: Other: Control group NIDCAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to remove the external feeding device
To perform a proper calculation, the investigator must quantify the days of life in which the feeding device is placed and the date of effective removal
Measured: Days of life of the baby when the external feeding device is removed assessed up to 30 days
Secondary outcomes (7)
Volume of intake at discharge
To perform a proper calculation, the investigator must quantify the volumen of milk in millilitres from the day of device removal until hospital discharge.
Measured: Milliliters that the baby take orally until the day of hospital discharge up to 4 weeks
Hospitalization days
Quantify the days from birth to hospital discharge.
Measured: Days that the premature baby remains hospitalized from birth to hospital discharge up to 12 weeks
Breastfeeding patients after hospital discharge
Quantify the babies who perform Breastfeeding, Deferred breastfeeding or Artificial Breastfeeding according to the group assigned at discharge.
Measured: Number of patients who are breast-feeding after hospital discharge up to 12 weeks
Deferred breastfeeding patients after hospital discharge
Quantify the babies who perform Breastfeeding, Deferred breastfeeding or Artificial Breastfeeding according to the group assigned at discharge
Measured: Number of patients who are Deferred breast-feeding after hospital discharge ,up to 12 weeks
Formula feeding patients after hospital discharge
Quantify the babies who perform Breastfeeding, Deferred breastfeeding or Artificial Breastfeeding according to the group assigned at discharge.
Measured: Number of patients who are formula feeding after hospital discharge, up to 12 weeks
Weight at hospital discharge
To estimate the existence of significant differences between the group that presented intervention and the control.
Measured: Assess weight discharge day, up to 12 weeks
Weight ten days at hospital discharge
Differences between discharge and 10-day weights
Measured: Assess weight ten days at hospital discharge, up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start13 Feb 2023
- Primary completion3 Jun 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for DysphagiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Assignment: Random and parallel using the OxMaR (Oxford Minimization and Randomization) software * Age range: 29-30 gestational weeks, both sexes will participate * Control group: Will receive the traditional intervention model of the Neonatal Intensive Care Unit (non-nutritive suction and kangaroo method) o Experimental group: Application of the PIOMI (Premature Infant Oral Motor Intervention) protocol, for 5 minutes twice a day, in a period of 10 days o Both groups will receive gustatory and olfactory stimulation * Intervention model: Parallel assignment * Description of the intervention model: Comparison of two groups, treated with the application of the care model in the NICU (Neonatal Intensive Care Unit) and the application of PIOMI (Premature Infant Oral Motor Intervention)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Sant Joan de Déu
- Sponsor type
- University, hospital or other
- Collaborators
- Sociedad Espanola de Gastroenterologia, Hepatologia y Nutricion Pediatrica, Nexe Foundation, University Ramon Llull, Borja Institute of Bioethics, Institut de Recerca Sant Joan de Déu
- Responsible party
- Sponsor
- Investigators
- Raquel García Ezquerra, Principal investigator, Sant Joan de Déu HospitalVanesa Ejarque Marin, Principal investigator, Sant Joan de Déu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395298
- Sponsor's protocol ID
- C.I.PIC-108-22
- Acronym
- PIOMI
- Status last verified
- Apr 2024
- First submitted
- 9 Jan 2023
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Initially, the researchers plan to share the study protocol, the statistical analysis and the summary of results obtained, both in congresses and in publications, if applicable.
Publications
Grassi R, Farina R, Floriani I, Amodio F, Romano S. Assessment of fetal swallowing with gray-scale and color Doppler sonography. AJR Am J Roentgenol. 2005 Nov;185(5):1322-7. doi: 10.2214/AJR.04.1114.
PubMed 16247157Ghomi H, Yadegari F, Soleimani F, Knoll BL, Noroozi M, Mazouri A. The effects of premature infant oral motor intervention (PIOMI) on oral feeding of preterm infants: A randomized clinical trial. Int J Pediatr Otorhinolaryngol. 2019 May;120:202-209. doi: 10.1016/j.ijporl.2019.02.005. Epub 2019 Feb 5.
PubMed 30851536Lessen BS. Premature infant oral motor intervention (PIOMI) translating interventional research into interdisciplinary practice [Internet]. Unpublished; 2012. Disponible en: http://dx.doi.org/10.13140/RG.2.1.3652.696
Shailaja S J, Jayashri S K. Comparative study on the effect of oral motor intervention protocols on oral motor skills of preterm infants from tertiary care hospital in metropolitan city: pilot study. Int J ContempPediatr [Internet]. 2020;7(7):1506.
Tian X, Yi LJ, Zhang L, Zhou JG, Ma L, Ou YX, Shuai T, Zeng Z, Song GM. Oral Motor Intervention Improved the Oral Feeding in Preterm Infants: Evidence Based on a Meta-Analysis With Trial Sequential Analysis. Medicine (Baltimore). 2015 Aug;94(31):e1310. doi: 10.1097/MD.0000000000001310.
PubMed 26252313Pickler RH, Best A, Crosson D. The effect of feeding experience on clinical outcomes in preterm infants. J Perinatol. 2009 Feb;29(2):124-9. doi: 10.1038/jp.2008.140. Epub 2008 Oct 2.
PubMed 18830247Boiron M, Da Nobrega L, Roux S, Henrot A, Saliba E. Effects of oral stimulation and oral support on non-nutritive sucking and feeding performance in preterm infants. Dev Med Child Neurol. 2007 Jun;49(6):439-44. doi: 10.1111/j.1469-8749.2007.00439.x.
PubMed 17518930Lessen BS. Effect of Oral Stimulation on Feeding Progression in Preterm Infants. Adv Neonatal Care [Internet]. 2009 Aug [cited 2021 Feb 14];9(4):187. Available from: https://journals.lww.com/00149525-200908000-00021
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Application of PIOMI (Premature Oral Motor Intervention) in the Oral Feeding of the Premature: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06395298
- Acronym / sponsor ID
- PIOMI / C.I.PIC-108-22
- Conditions
- Dysphagia, Disorder; Feeding, Newborn, Premature
- Keywords
- Swallowing, Swallowing disorders, Nutritional support, Feeding disorders, Preterm, Neonates, Sucking Behavior
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Fundació Sant Joan de DéuUniversity, hospital or other
- Collaborators
- Sociedad Espanola de Gastroenterologia, Hepatologia y Nutricion Pediatrica, Nexe Foundation, University Ramon Llull, Borja Institute of Bioethics, Institut de Recerca Sant Joan de Déu
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 3 Jun 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 2 May 2024 (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 goal of this clinical trial is assess whether the application of the premature oral motor intervention (PIOMI) combined with the Newborn Individualized Developmental Care and Assessment Program (NIDCAP), allows withdrawal of the external feeding device with guarantees of the patient's nutritional status, determining breastfeeding rates at hospital discharge and swallowing safety earlier than if only the care activity corresponding to the NIDCAP model is carried out, as well as the applicability of this standardised protocol in the neonatal intensive care unit of a tertiary hospital.
Detailed description
Prematurity is one of the most common factors affecting the development of oromotor skills, interfering with feeding. The most common clinical manifestation is uncoordinated sucking-breathing-swallowing cycle.
The incidence of oropharyngeal dysphagia in paediatrics is estimated at 10.40%, doubling in preterm infants weighing less than 1500 grams. The aetiological distribution of swallowing disorders in the neonatal age is highly variable, as is their clinical presentation. Current literature reflects the impact of the use of an external feeding device on the quality of life of the patient-family, as well as the increased health care costs due to prolonged hospitalisation, emergencies for device removal, consumables and enteral nutrition.
Current health models are based on prevention, hence the importance of establishing early protocols for assessment, diagnosis and intervention. The main difficulty in neonatal intensive care units is the loss of opportunity for oral feeding and the absence of standardised protocols, as there is great controversy regarding the intervention techniques that should be applied to promote the development of oral-motor skills.The PIOMI is the intervention model that currently presents the greatest scientific production, the results obtained in the studies carried out show a high success rate in relation to the initiation of oral feeding in preterm infants, as well as the maintenance of high breastfeeding rates at the time of hospital discharge and at 10 days, in compliance with the standards of the World Health Organisation (WHO).
At present, there are study designs of PIOMI, combined with olfactory-gustatory stimulation, but the latter is not specified as an oropharyngeal colostrum technique, which is currently indicated in the therapeutic guidelines, nor is the protocolised nursing care model described, an aspect that is of great importance because each hospital centre offers different care depending on whether or not the model is based on the individualised assessment and care programme for the development of the newborn.
This research aims to evaluate these aspects by means of a randomised double-blind parallel allocation clinical trial using Oxford Minimization and Randomization (OxMaR) software, to be carried out at the Hospital Sant Joan de Déu in Barcelona, in the neonatal intensive care unit in the period November 2023-2026. The sample size is n=35 preterm infants of gestational age 29-30+6.
The control group will follow the NIDCAP care model and the experimental group will apply the PIOMI+NIDCAP protocol for 5 minutes twice a day for 10 days, with olfactory stimulation and oropharyngeal colostrum for both groups.
The family will apply the intervention by accessing a quick response code with an information capsule according to the assigned group.
To identify factors, sociodemographic and health variables, process variables and outcome variables will be selected using the Neonatal Oral-motor Assessment Scale (NOMAS), Early Feeding Skills Assessment (EFSA) and pre- and post-tests will be analysed using variance analysis program (ANOVA) and statistical package for the social sciences (SPSS)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- * Assignment: Random and parallel using the OxMaR (Oxford Minimization and Randomization) software * Age range: 29-30 gestational weeks, both sexes will participate * Control group: Will receive the traditional intervention model of the Neonatal Intensive Care Unit (non-nutritive suction and kangaroo method) o Experimental group: Application of the PIOMI (Premature Infant Oral Motor Intervention) protocol, for 5 minutes twice a day, in a period of 10 days o Both groups will receive gustatory and olfactory stimulation * Intervention model: Parallel assignment * Description of the intervention model: Comparison of two groups, treated with the application of the care model in the NICU (Neonatal Intensive Care Unit) and the application of PIOMI (Premature Infant Oral Motor Intervention)
| Arm | Type | Receives |
|---|---|---|
| Experimental Group PIOMI | Experimental | Other: Experimental group PIOMIParticipants will receive: 1. The traditional intervention Newborn Individualized Development Care and Assessment Program (NIDCAP) model of the Neonatal Intensive Care Unit (NICU) .The nurse providing direct care to the patient and family, will carry out the relevant care of the patient. 2. The Premature Oral Motor Intervention (PIOMI) .The family will apply the PIOMI , 7 activities are intraoral stimulation for 10 consecutive days, twice a day, 5 minutes. 3. Gustatory stimulation technique:the application of oropharyngeal colostrum, a 0.5 milliliter twice a day 4. Olfactory stimulation Technique:A swab is moistened in breast milk and placed near the nose for one minute, twice a day. |
| Control Group NIDCAP | Sham comparator | Other: Control group NIDCAPParticipants will receive : 1.The traditional intervention Newborn Individualized Development Care and Assessment Program (NIDCAP) model of the Neonatal Intensive Care Unit (NICU).The nurse providing direct care to the patient and family, will carry out the relevant care of the patient. 3.Gustatory stimulation technique:the application of oropharyngeal colostrum, a 0.5 milliliter twice a day 4.Olfactory stimulation Technique:A swab is moistened in breast milk and placed near the nose for one minute, twice a day. |
Who may qualify
- Ages
- 29 to 30 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Neonates born at the Sant Joan de Déu Hospital with a gestational age between 29-30 weeks carrying an external feeding device due to the difficulty of oral feeding and that the medical team in charge considers clinically stable.
Key exclusion criteria (4 listed)
- Endotracheal intubation or high-flow ventilatory support.
- Exclusive parenteral nutrition.
- Hyporeactive due to the use of sedative drugs.
- Condition of prematurity associated with other pathologies (syndromes, acquired brain damage, gastrointestinal malformations, airway and craniofacial malformations).
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 |
|---|---|---|
| Experimental group PIOMIAlso: PIOMI+NIDCAPA group treated with the application of the care model Newborn Individualized Development Care and Assessment Program (NIDCAP) in the Neonatal Intensive Unit Care (NICU)+PIOMI | Other | Experimental Group PIOMI |
| Control group NIDCAPAlso: NIDCAPA group treated with the application of the care model Newborn Individualized Development Care and Assessment Program (NIDCAP) in the Neonatal Intensive Unit Care (NICU) | Other | Control Group NIDCAP |
Primary outcome
Time to remove the external feeding device
Time frame: Days of life of the baby when the external feeding device is removed assessed up to 30 days
To perform a proper calculation, the investigator must quantify the days of life in which the feeding device is placed and the date of effective removal
7 secondary outcomes
Volume of intake at discharge
Time frame: Milliliters that the baby take orally until the day of hospital discharge up to 4 weeks
Hospitalization days
Time frame: Days that the premature baby remains hospitalized from birth to hospital discharge up to 12 weeks
Breastfeeding patients after hospital discharge
Time frame: Number of patients who are breast-feeding after hospital discharge up to 12 weeks
Deferred breastfeeding patients after hospital discharge
Time frame: Number of patients who are Deferred breast-feeding after hospital discharge ,up to 12 weeks
Formula feeding patients after hospital discharge
Time frame: Number of patients who are formula feeding after hospital discharge, up to 12 weeks
Weight at hospital discharge
Time frame: Assess weight discharge day, up to 12 weeks
Weight ten days at hospital discharge
Time frame: Assess weight ten days at hospital discharge, up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Background: PubMed 16247157Grassi R, Farina R, Floriani I, Amodio F, Romano S. Assessment of fetal swallowing with gray-scale and color Doppler sonography. AJR Am J Roentgenol. 2005 Nov;185(5):1322-7. doi: 10.2214/AJR.04.1114.
- Background: PubMed 30851536Ghomi H, Yadegari F, Soleimani F, Knoll BL, Noroozi M, Mazouri A. The effects of premature infant oral motor intervention (PIOMI) on oral feeding of preterm infants: A randomized clinical trial. Int J Pediatr Otorhinolaryngol. 2019 May;120:202-209. doi: 10.1016/j.ijporl.2019.02.005. Epub 2019 Feb 5.
- BackgroundLessen BS. Premature infant oral motor intervention (PIOMI) translating interventional research into interdisciplinary practice [Internet]. Unpublished; 2012. Disponible en: http://dx.doi.org/10.13140/RG.2.1.3652.696
- BackgroundShailaja S J, Jayashri S K. Comparative study on the effect of oral motor intervention protocols on oral motor skills of preterm infants from tertiary care hospital in metropolitan city: pilot study. Int J ContempPediatr [Internet]. 2020;7(7):1506.
- Background: PubMed 26252313Tian X, Yi LJ, Zhang L, Zhou JG, Ma L, Ou YX, Shuai T, Zeng Z, Song GM. Oral Motor Intervention Improved the Oral Feeding in Preterm Infants: Evidence Based on a Meta-Analysis With Trial Sequential Analysis. Medicine (Baltimore). 2015 Aug;94(31):e1310. doi: 10.1097/MD.0000000000001310.
- Background: PubMed 18830247Pickler RH, Best A, Crosson D. The effect of feeding experience on clinical outcomes in preterm infants. J Perinatol. 2009 Feb;29(2):124-9. doi: 10.1038/jp.2008.140. Epub 2008 Oct 2.
- Background: PubMed 17518930Boiron M, Da Nobrega L, Roux S, Henrot A, Saliba E. Effects of oral stimulation and oral support on non-nutritive sucking and feeding performance in preterm infants. Dev Med Child Neurol. 2007 Jun;49(6):439-44. doi: 10.1111/j.1469-8749.2007.00439.x.
- BackgroundLessen BS. Effect of Oral Stimulation on Feeding Progression in Preterm Infants. Adv Neonatal Care [Internet]. 2009 Aug [cited 2021 Feb 14];9(4):187. Available from: https://journals.lww.com/00149525-200908000-00021
- Individual participant dataSharing planned: Yes. Initially, the researchers plan to share the study protocol, the statistical analysis and the summary of results obtained, both in congresses and in publications, if applicable.
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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.
Raquel García Ezquerra principal investigator
Sant Joan de Déu Hospital
Vanesa Ejarque Marin principal investigator
Sant Joan de Déu Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group PIOMI in people with Dysphagia and Disorder; Feeding, Newborn, run by Fundació Sant Joan de Déu at 1 site in Spain.
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 1 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: looking for participants now, as of the sponsor's last update on 2 May 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raquel García Equerra (639423251, raquel.garciae@sjd.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to remove the external feeding device (time frame: Days of life of the baby when the external feeding device is removed assessed up to 30 days). 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 NCT06395298, which also lists 8 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 2 May 2024.