PIOMI combined with Cold Non-Nutritive Sucking in premature infants

Effect of Premature Infant Oral Motor Intervention (PIOMI) combined with Cold Non-Nutritive Sucking on feeding progression in premature infants with feeding Problems admitted to the NICU- A Randomized Clinical Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20241223064134N1

Enrollment

Registered

2025-03-04

Start date

2025-02-19

Completion date

Unknown

Last updated

2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral feeding disorders in premature infants. Other dysphagia

Interventions

Intervention 1: Intervention group: Present Premature Infant Oral Motor Intervention (PIOMI) intervention before feeding and for 5 minutes a day for seven consecutive days and implement cold Non-Nutr

Eligibility

Sex/Gender

All

Age

196 Days to 238 Days

Inclusion criteria

Inclusion criteria: gestational age between 28-34 weeks , weight between 1000 and 2000g no neuropathy no unspecified incompatibility no previous medical history birth weight between 1000 and 2000g Receiving tube feeding and the baby's inability to feed orally Apgar score equal or more than 6 at 5 minutes after birth physiological stability during oral stimulations no severe or chronic medical status or congenital anomalies no neuropathy no unspecified incompatibility no drug addiction or infectious diseases in mothers of premature infants no previous medical history

Exclusion criteria

Exclusion criteria: premature infants who have physiological instability during oral intervention Family's unwillingness to continue treatment

Design outcomes

Primary

Measure	Time frame
Preterm infant oral feeding readiness assessment scale. Timepoint: First, fourth and seventh days of intervention. Method of measurement: Preterm infant oral feeding readiness assessment scale.	—

Secondary

Measure	Time frame
Weight gain. Timepoint: First, fourth and seventh days of intervention. Method of measurement: Put the baby on a digital balance and record the baby's weight to gram.;Duration of the hospitalization. Timepoint: First, fourth and seventh days of intervention. Method of measurement: Interval between the first day of preterm infant referral to the NICU until the last day (discharge).;Time required to achieve full oral nutrition. Timepoint: First, fourth and seventh days of intervention. Method of measurement: The interval between the first day of intervention and the last day of achieving full oral nutrition.	—

Measure

Time frame

Weight gain. Timepoint: First, fourth and seventh days of intervention. Method of measurement: Put the baby on a digital balance and record the baby's weight to gram.;Duration of the hospitalization. Timepoint: First, fourth and seventh days of intervention. Method of measurement: Interval between the first day of preterm infant referral to the NICU until the last day (discharge).;Time required to achieve full oral nutrition. Timepoint: First, fourth and seventh days of intervention. Method of measurement: The interval between the first day of intervention and the last day of achieving full oral nutrition.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNarges Serajinezhad

Ahvaz University of Medical Sciences

n.seraji2019@gmail.com+98 61 3311 0000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026