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The effect of oral motor intervention with different initiation times to improve feeding outcomes in preterm infants: protocol for a single-blind, randomized controlled trial

The effect of oral motor intervention with different initiation times to improve feeding outcomes in preterm infants

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076721
Enrollment
Unknown
Registered
2023-10-17
Start date
2023-10-20
Completion date
Unknown
Last updated
2023-10-22

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

Conditions

preterm infant

Interventions

early OMIs group:On the basis of routine care, an oral motor intervention program developed by American scholar Fucile and translated into Chinese by domestic scholar Lv Tianchan was implemented. The
Late OMIs group:OMIs interventions were started 48 hours after discontinuation of nasal continuous positive airway pressure.

Sponsors

West China Second University Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Eligible for preterm diagnosis, birth weight of <2500g and gestational age of 29+0 to 34+6 weeks, 2.appropriate for gestational age; 3.Stable vital signs; 4.No major congenital anomalies (such as congenital heart disease, congenital digestive tract malformations); 5. Inclusion requires non-invasive ventilation support (including high-flow nasal cannula).

Exclusion criteria

Exclusion criteria: 1. Mechanical ventilation 2. Severe asphyxia 3. Previously enrolled in other studies. 4. Necrotizing enterocolitis, NEC 5. Periventricular Leukomalacia 6.Intracranial Hemorrhage Grade >= III

Design outcomes

Primary

MeasureTime frame
Transition time;

Secondary

MeasureTime frame
feeding efficiency (average milk intake per minute) ;feeding effectiveness (oral intake in the first 5 minutes / prescribed intake).;The neonatal oral-motor assessment scale(NOMAS) scores;weight;hospital stay;height;Head circumference;neurodevelopment outcome;adverse event rate;

Countries

China

Contacts

Public ContactQiong Chen

West China Second University Hospital, Sichuan University

chenqiong_66@scu.edu.cn+86 181 8060 3872

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026