An interventional study of The PIOMI initiative in maternal interaction and Control in Preterm and Preterm Infant Development, sponsored by Ataturk University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 28 Weeks to 32 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Ataturk University · Not applicable, Interventional, and Supportive care
Premature Infant Oral Motor Intervention (PIOMI) has been found to improve short-term clinical outcomes in preterm infants and contribute to their feeding skills. In preterm infants, PIOMI can improve weight and facilitate early oral feeding. Furthermore, PIOMI can shorten the length of hospital stay and the separation time between the infant and caregiver in preterm infants. The primary aim of this project is to evaluate the effect of PIOMI in mother-infant interaction (applied with the infant in the mother's arms and accompanied by the mother's voice) on feeding readiness, suckling success, mothers' breastfeeding attitudes and infants' feeding maturity in preterm newborns. The secondary objective is to investigate whether PIOMI applied in mother-infant interaction affects mothers' positive and negative emotional states.
2,610 studies on the registry are indexed under Premature Birth; 507 are open to participants now.
This study's planned enrollment of 66 is below the median of 84 across 1,722 interventional studies indexed under Premature Birth.
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Exclusion Criteria:
The PIOMI application will be administered to the control group.
Other: Control
The PIOMI intervention will be administered to the experimental group during maternal interaction.
Other: The PIOMI initiative in maternal interaction
PIOMI will be administered to preterm infants at YYBÜ alongside feeding procedures. This therapy will be administered once daily for seven consecutive days by the same practitioner, with maternal interaction.
PIOMI application
Total Swallow Count
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.
Time frame: 1-7 day
Respiration Rate (bpm)
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.
Time frame: 1-7 day
Inspirium After Swallow Count
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.
Time frame: 1-7 day
Overlapped Inspirium After Swallow Events: Overlapped Inspirium After Swallow Percentage & Average Overlapped Inspirium After Swallow Duration
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.
Time frame: 1-7 day
Maximum Rhythmic Swallow
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.
Time frame: 1-7 day
Minimum Rhythmic Swallow
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.
Time frame: 1-7 day
Average Time Between Rhythmic Swallows
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.
Time frame: 1-7 day
Resting Interval Count
Description: Total number of rest intervals when rhythmic swallowing is not observed.
Time frame: 1-7 day
Preterm Infant Oral Feeding Readiness
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
Time frame: 1-7 day
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