Trial · NCT07894380
Nutritional Maturity in Preterm Newborns (Premature Infant Oral Motor Intervention, PIOMI)
NCT07894380, Not applicable, Recruiting, Ataturk University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Nutritional Maturity in Preterm Newborns (Premature Infant Oral Motor Intervention, PIOMI). Trials, record NCT07894380. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07894380
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nutritional Maturity in Preterm Newborns (Premature Infant Oral Motor Intervention, PIOMI)
- NCT number
- NCT07894380
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 66 participants, estimated
- Lead sponsor
- Ataturk University
- Conditions
- Preterm, Preterm Infant Development
- Interventions
- The PIOMI initiative in maternal interaction, Control
- First posted
- 2026-10-26
- Last updated
- 2026-10-26
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Swallow Count | 1-7 day | The Neonatal Oral Feeding Monitor is a non-invasive medical device designed to assess feeding maturity. NeoSAFE takes measurements using two sensors. These sensors are placed under the infant's chin in the hyoid region and on the right abdominal area below the diaphragm to monitor the infant's respiration and swallowing movements during oral feeding. To ensure adequate monitoring, the procedure is carried out for at least two minutes while the data stream from the monitor is observed. Data collected via the sensors are categorized to evaluate the infant's feeding maturity. Description: Total number of detected swallows during feeding. |
| Primary | Respiration Rate (bpm) | 1-7 day | Description: The amount of infant breath moments recorded per minute during the feeding session. It is expressed in breaths per minute (bpm) and reflects the respiratory function and oxygenation of the infant. |
| Primary | Inspirium After Swallow Count | 1-7 day | Description: Number of detected inspirium after swallowing events in a feeding session. This parameter is analyzed in two groups: inspiriums that overlap with swallow events and inspiriums that do not overlap with swallows but the interval in between is too short which may lead to aspiration. The total number of Inspirium After Swallow 's is obtained by summing these two groups. |
| Primary | Overlapped Inspirium After Swallow Events: Overlapped Inspirium After Swallow Percentage & Average Overlapped Inspirium After Swallow Duration | 1-7 day | Description: Overlapped Inspirium After Swallow events represent the number of inspirium states that overlap with swallows. The overlapped Inspirium After Swallow percentage expresses the average percentage of the ratio of the overlap time to total swallow time, whereas the average overlapped Inspirium After Swallow duration represents the average duration of the overlapping inspirium with swallows. These parameters can be better understood with numerical examples, as in the following sections. |
| Primary | Maximum Rhythmic Swallow | 1-7 day | Description: The maximum number of swallows that the infant can perform in a rhythmic cycle without a resting interval. This parameter represents the number of swallows in the longest rhythmic cycle that the infant demonstrates. It indicates how well the infant can swallow without requiring rest intervals. A higher number suggests that the infant can swallow more smoothly and effectively, while a lower number indicates the need for more rest intervals between swallows. |
| Primary | Minimum Rhythmic Swallow | 1-7 day | Description: The minimum number of swallows that the infant can perform in a rhythmic cycle without any rest interval. This parameter reflects the infant's swallowing consistency and stability. A higher value indicates the infant can maintain a regular swallowing pattern, while a lower value implies more variability in their swallowing rhythm. |
| Primary | Average Time Between Rhythmic Swallows | 1-7 day | Description: The average time of the intervals between consecutive rhythmic swallow groups. This parameter shows the infant's resting behavior. A longer interval indicates that the infant takes more extended breaks between the rhythmic swallow events, while a shorter interval suggests the infant swallows more rapidly and smoothly. |
| Primary | Resting Interval Count | 1-7 day | Description: Total number of rest intervals when rhythmic swallowing is not observed. |
| Secondary | Preterm Infant Oral Feeding Readiness | 1-7 day | Preterm Infant Oral Feeding Readiness Assessment Scale (T-POFRAS): T-POFRAS is an observational scale developed by Fujinaga et al. It consists of 18 items across five categories (corrected gestational age, behavioral organization, oral posture, oral reflexes, and non-nutritive sucking) and assesses oral feeding readiness in preterm infants. The scale is scored from 0 to 2 per item, with a maximum total score of 36. The cutoff score for transitioning a preterm infant to oral feeding was established as 30 (Fujinaga et al., 2013). In the Turkish adaptation of the scale-validated for reliability and validity by Çamur and Çetinkaya-the cutoff score was determined to be 29 (Çamur \& Çetinkaya, 2021). The assessment of the preterm infant using T-POFRAS is conducted as follows: prior to the scheduled feeding time, the researcher first places the infant-who is inside the incubator-in a lateral decubitus position. The infant is awakened through gentle tactile stimulation or by being called by na |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07894380
GET https://conductscience.org/api/trials/v1/NCT07894380/registered