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The impact of oral motor intervention on the asymmetric development of brain functional networks in premature infants: A randomized controlled study based on resting-state fNIRS

The impact of oral motor intervention on the asymmetric development of brain functional networks in premature infants: A randomized controlled study based on resting-state fNIRS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600126146
Enrollment
Unknown
Registered
2026-06-04
Start date
2026-06-08
Completion date
Unknown
Last updated
2026-06-08

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

Conditions

Brain injury in premature newborns

Interventions

intervention group (conventional care + oral motor intervention):Based on routine care in the NICU, the PIOMI oral motor intervention program was implemented once daily for 12 minutes each time, with
2. Comprehensive gum stimulation and massage: 2 minutes
3. Tongue temperature mild stimulation and activity training: 2 minutes
4. Non-nutritive sucking training (medical pacifier): 6 minutes.
Control group (conventional NICU care):Implement standardized routine care for neonatology, including body position management, warmth care, infection prevention and control, and tube feeding/oral fee
routinely provide pacifiers for basic non-nutritive sucking, without performing systematic perioral massage, gingival stimulation, or tongue intervention. The remaining medical, nursing, and feeding r

Sponsors

Maternity and Child Healthcare Hospital of Lianyungang
Lead Sponsor

Eligibility

Sex/Gender
All
Age
28 Weeks to 34 Weeks

Inclusion criteria

Inclusion criteria: 1. Gestational age at birth: 28-34 weeks; 2. Birth weight <= 1800g; 3. Enrolled within 48 hours after birth, with stable vital signs and circulatory and respiratory functions; 4. The guardians provided informed consent, voluntarily participated in this study, and cooperated with follow-up visits and data collection.

Exclusion criteria

Exclusion criteria: 1. Severe intracranial lesions: Grade III or above intracranial hemorrhage, periventricular leukomalacia, moderate to severe hypoxic ischemic encephalopathy; 2. Severe respiratory disease requiring invasive mechanical ventilation for more than 7 days; 3. Congenital oral and facial malformations, digestive tract malformations, and congenital developmental abnormalities of the central nervous system; 4. Identify genetic and metabolic diseases, severe infections, and multiple organ dysfunction; 5. The mother had a long history of alcohol abuse, drug use, and severe use of psychiatric medications during pregnancy; 6. The guardian refused to cooperate with intervention, image acquisition, and clinical data collection.

Design outcomes

Primary

MeasureTime frame
deoxyhemoglobin (HbR) concentrations (Bilateral frontal lobe, temporal lobe, parietal lobe, occipital lobe);

Secondary

MeasureTime frame
Oxyhemoglobin (HbO);Feeding outcomes (transition days for full oral feeding, feeding efficiency);Development indicators (daily weight gain rate, head circumference growth rate);Neonatal Behavioral Neurological Assessment;

Countries

China

Contacts

Public ContactDong Li

Maternity and Child Healthcare Hospital of Lianyungang City, Jiangsu Province

45086096@163.com+86 180 3662 6070

Outcome results

None listed

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