Premature InfantPhase 3NCT03911674
Effects of Oral Stimulation in Preterm Infants
A Phase 3 study testing Oral manual stimulation of feeding in preterm infants in people with Premature Infant and Eating Disorder, run by CEU San Pablo University at 1 site in Spain.
Trial summary
Preterm infants with gestational age inferior to 34 weeks were included in the study. A prospective experimental group received the oral stimulation protocol and the effects of the intervention were compared with a historical control group that did not receive any oral stimulation intervention. Read more about this study
- Who is it for?
- Ages Up to 7 days
- Conditions the study is for
- Premature Infant, Eating Disorder
- What is being tested?
- Oral manual stimulation of feeding in preterm infants
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2017to 1 Apr 2018
- Phase
- Phase 3
- 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 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants with gestational age inferior to 34 weeks
Who cannot join
- Instability caused by respiratory, cardiac or gastrointestinal issues
- Orofacial malformations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Oral Stimulation on Feeding Performance, Length of Hospital Stay and Anthropometric Variables of Preterm Infants
Preterm infants with gestational age inferior to 34 weeks were included in the study. A prospective experimental group received the oral stimulation protocol and the effects of the intervention were compared with a historical control group that did not receive any oral stimulation intervention.
The study hypothesis is that oral stimulation in preterm infants has beneficial effects on the feeding performance, the length of hospitalization and anthropometric variables, including weight at discharge, height at discharge and head circumference at discharge.
- Conditions
- Premature Infant, Eating Disorder
- Being tested
- Oral manual stimulation of feeding in preterm infants
- Medical subject headings
- Premature Birth, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral manual stimulation of feeding in preterm infantsOther
Manual stimulation of the cheeks (internal and external), lips, gums, tongue and palate by finger-strokin.
| Study group | Role | What they receive |
|---|---|---|
| Oral stimulation | Experimental | Oral stimulation protocol: manual stimulation of the oral sucking Receives: Other: Oral manual stimulation of feeding in preterm infants |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational age at the initiation of oral feeding
Measured: Up to 46 weeks
Weight at discharge (g)
Measured: Up to 46 weeks
Height at discharge (cm)
Measured: Up to 46 weeks
Head circumference at discharge (cm)
Measured: Up to 46 weeks
Days of enteral nutrition
Measured: Up to 46 weeks
Gestational age at discharge (weeks)
Measured: Up to 46 weeks
Total length of hospitalization
Measured: Up to 46 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start1 Sep 2017
- Primary completion1 Apr 2018
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- CEU San Pablo University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03911674
- Sponsor's protocol ID
- CEU-0013
- Status last verified
- Apr 2019
- First submitted
- 31 Mar 2019
- Last updated
- 11 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Stimulation on Feeding Performance, Length of Hospital Stay and Anthropometric Variables of Preterm Infants
- ClinicalTrials.gov ID
- NCT03911674
- Acronym / sponsor ID
- CEU-0013
- Conditions
- Premature Infant, Eating Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- CEU San Pablo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 11 Apr 2019 (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.
Preterm infants with gestational age inferior to 34 weeks were included in the study. A prospective experimental group received the oral stimulation protocol and the effects of the intervention were compared with a historical control group that did not receive any oral stimulation intervention.
The study hypothesis is that oral stimulation in preterm infants has beneficial effects on the feeding performance, the length of hospitalization and anthropometric variables, including weight at discharge, height at discharge and head circumference at discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral stimulation | Experimental | Other: Oral manual stimulation of feeding in preterm infantsOral stimulation protocol: manual stimulation of the oral sucking |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Preterm infants with gestational age inferior to 34 weeks
Key exclusion criteria (2 listed)
- Instability caused by respiratory, cardiac or gastrointestinal issues
- Orofacial 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 |
|---|---|---|
| Oral manual stimulation of feeding in preterm infantsManual stimulation of the cheeks (internal and external), lips, gums, tongue and palate by finger-strokin. | Other | Oral stimulation |
Primary outcome
Gestational age at the initiation of oral feeding
Time frame: Up to 46 weeks
Weight at discharge (g)
Time frame: Up to 46 weeks
Height at discharge (cm)
Time frame: Up to 46 weeks
Head circumference at discharge (cm)
Time frame: Up to 46 weeks
Days of enteral nutrition
Time frame: Up to 46 weeks
Gestational age at discharge (weeks)
Time frame: Up to 46 weeks
Total length of hospitalization
Time frame: Up to 46 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oral manual stimulation of feeding in preterm infants in people with Premature Infant and Eating Disorder, run by CEU San Pablo University 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 2 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: finished, as of the sponsor's last update on 11 Apr 2019. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Gestational age at the initiation of oral feeding (time frame: Up to 46 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2019.