Single-Session Physiotherapy Versus Massage in Premature Infants (SPIM-Preterm)

Necmettin Erbakan University

Status: Completed

Conditions: Preterm Infants

Treatments: Behavioral: Infant Massage; Behavioral: Physiotherapy (Moyer-Mileur Protocol)

Study type: Interventional

Funder types: Other

Identifiers

NCT07207161

23090

Details and patient eligibility

About

This study investigates the effects of a single-session physiotherapy intervention compared to massage in premature infants hospitalized in the neonatal intensive care unit. Premature babies are vulnerable to stress, pain, and sleep disturbances due to medical procedures and the intensive care environment. The study aims to evaluate whether physiotherapy or massage can reduce stress and pain, improve sleep, bilirubin levels, and cerebral oxygenation. Infants will be randomly assigned to three groups: control (routine care), massage, and physiotherapy (Moyer-Mileur protocol). The results will contribute to developing evidence-based interventions to support the health and development of premature infants

Enrollment: 60 patients

Sex: All

Ages: Under 1 month old

Volunteers: No Healthy Volunteers

Inclusion criteria

Preterm infants born between 20 and 37 gestational weeks

Apgar score ≥ 4 at the 5th minute after birth

Parental consent obtained for participation

Infants able to receive oxygen via CPAP (Continuous Positive Airway Pressure) or nasal prongs during the intervention if necessary

Exclusion criteria

Congenital anomalies or chromosomal abnormalities

Chronic medical conditions such as bronchopulmonary dysplasia

Intraventricular hemorrhage grade III or IV (IVH)

Necrotizing enterocolitis (NEC)

Asphyxia or seizures

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Control Group

No Intervention group

Description:

Infants in this group will receive routine neonatal intensive care without any additional physiotherapy or massage intervention. This arm serves as the standard care control group.

Massage Group

Experimental group

Description:

Infants in this group will receive infant massage as an intervention. Massage will be performed by a trained physiotherapist following a standardized protocol. The purpose is to evaluate the effects of massage on physiological stability, weight gain, and overall development in premature infants.

Treatment:

Behavioral: Infant Massage

Physiotherapy Group

Experimental group

Description:

Infants in this group will receive a single-session physiotherapy intervention based on the Moyer-Mileur protocol. The intervention includes gentle range of motion and flexion-extension exercises designed to stimulate neuromuscular development in premature infants. The effects will be compared with those of massage and routine neonatal care.

Treatment:

Behavioral: Physiotherapy (Moyer-Mileur Protocol)