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Can Special Mouth Exercises and Extra Breastfeeding Support Help Premature Babies Feed Better Than Standard Hospital Care?

Effectiveness of Combined Premature Infant Oral Motor Intervention (PIOMI) and Structured Lactation Counselling versus standard care on Oral Feeding Transition in Preterm Infants: A Randomized Controlled Trial - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/110023
Enrollment
20
Registered
2026-05-04
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: P073- Preterm [premature] newborn [other]

Interventions

Intervention1: Premature Infant Oral Motor Intervention (PIOMI) And structured lactation counselling: Protocol: A standardized 5-minute oral motor stimulation program developed by Dr. Brenda Lessen (2

Sponsors

Anghitha Ann Tom
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: i. Preterm infant with post menstrual age (PMA) 32 to 37 weeks at the time of recruitment admitted in the NICU at St. John s Medical College Hospital during the study period4. ii. Hemodynamically stable infants (no vasopressor support) tolerating enteral feeds, on Room Air/CPAP/Low-flow oxygen 3, 4. iii. Parents who are willing to participate and provide informed consent for participation in the study iv. Parents with basic education (reading & writing skills)

Exclusion criteria

Exclusion criteria: i. Major malformations of the oral cavity (cleft lip/palate) or Central Nervous System (e.g., Neural Tube Defects, Hydrocephalus) 3. ii. Severe Neurological Morbidity: Intraventricular Haemorrhage (IVH) Grade III or IV, Periventricular Leukomalacia (PVL), or active seizures 4. iii. Gastrointestinal/Systemic Instability: Necrotizing Enterocolitis (NEC) Stage II+, or culture-proven sepsis requiring ventilatory escalation 4. iv. Maternal Factors: Mothers with medical contraindications to breastfeeding (e.g., chemotherapy) or inability to attend counselling sessions 5.

Design outcomes

Primary

MeasureTime frame
To understand the Transition Time (days) from gavage to independent oral feeding between the study groups.Timepoint: The day when they attain oral feeding—

Secondary

MeasureTime frame
1. To assess improvement in oral motor readiness using the POFRAS (Preterm Oral Feeding Readiness Assessment Scale).Timepoint: Day 1,3,7;2. To evaluate the quality of breastfeeding behaviour using the PIBBS (Preterm Infant Breastfeeding Behaviour Scale).Timepoint: Day 1,3,7;3. To compare the rate of Weight Gain (g or kg/day) and Length of Stay between the two groups.Timepoint: Day 1,3,7—

Countries

India

Contacts

Public ContactAnghitha Ann tom

St John s medical college

Anghitha.tom@stjohns.in6360295043

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026