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Effectiveness Of Osteopathic Manipulative Treatment In NICU: A Multicenter Clinical Trial

E

European Institute for Evidence Based Osteopathic Medicine

Status

Completed

Conditions

Prematurity

Treatments

Other: osteopathic manipulative treatment
Other: Usual care

Study type

Interventional

Funder types

Other

Identifiers

NCT01645137
Multi-NE-O

Details and patient eligibility

About

The use of complementary and alternative medicine in neonatal ward has been steadily rising during the last decade. This integrated medicine approach has been shown to be helpful to improve neonatal health care. Osteopathic manipulative treatment (OMT) has been applied to premature infants to reduce the length of stay and to cope with clinical complications. Results from previous studies documented the positive association between OMT and shorter period of hospitalisation as well as improvement of clinical conditions. The aim of this nationwide multicenter study is to demonstrate the effect of OMT on length of stay (LOS) in premature infants across 3 neonatal intensive care units (NICU).

Enrollment

690 estimated patients

Sex

All

Ages

29 to 37 weeks old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • preterm infants born at age between 29 and 37 weeks
  • osteopathic treatment performed < 14 days after birth
  • preterms born in the same hospital

Exclusion criteria

  • Gestational age < 29 weeks
  • Gestational age > 37 weeks
  • First OMT performed after 14 days from birth
  • 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

Quadruple Blind

690 participants in 2 patient groups

OMT
Experimental group
Description:
patients under usual medical care plus osteopathic treatment
Treatment:
Other: osteopathic manipulative treatment
control
Other group
Description:
patients under usual medical care
Treatment:
Other: Usual care

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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