Effect of Osteopathic Manipulative Treatment on Pain in Preterms

European Institute for Evidence Based Osteopathic Medicine

Status: Unknown

Conditions: Prematurity

Treatments: Other: Sham therapy; Other: Usual care; Other: Osteopathic manipulative treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02146677

NEO-Pa 1

Details and patient eligibility

About

Osteopathic manipulative treatment (OMT) has been used to treat term and preterm newborns. Recent studies demonstrated the effectiveness of OMT in reducing length of stay and costs (Cerritelli, 2013) as well as the likelihood of gastrointestinal episodes (Pizzolorusso 2011). Moreover it was reported the absence of adverse events and side effects considering the approach safe (Cerritelli 2013, 2014).

OMT was extensively used to treat, prevent and manage pain symptoms. Numerous research was published addressing acute and chronic pain in different medical conditions. However, no trials were carried out on pain in newborns. The aim of the present clinical trial is to explore the effectiveness of OMT in reducing pain in a sample of preterm infants.

Enrollment: 120 estimated patients

Sex: All

Ages: 26 to 37 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• preterm infants
• written informed consent by parents or legal guardians
• preterms born in the same hospital

Exclusion criteria

• Gestational age > 37 weeks
• genetic disorders
• congenital disorders
• cardiovascular abnormalities
• proven or suspected necrotized enterocolitis with or without gastrointestinal perforation
• proven or suspected abdominal obstruction
• pre/post surgery patients
• pneumoperitoneum
• atelectasis
• Newborn from an HIV seropositive/drug addicted mother
• respiratory disorders
• transferred to/from other hospital
• admitted for preterminal comfort care (defined as neither intubation nor cardio-respiratory resuscitation)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups

Sham

Other group

Description:

newborns will be osteopathically evaluated and softly touched

Treatment:

Other: Sham therapy

Other: Usual care

Usual care

Other group

Description:

newborns will be undergone usual routine neonatology care

Treatment:

Other: Usual care

OMT

Other group

Description:

newborns will receive osteopathic evaluation and treatment according to international guidelines. Osteopathic treatment use will be indirect techniques.

Treatment:

Other: Osteopathic manipulative treatment

Other: Usual care