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NCT Number: NCT01645137

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

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).

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Key information

Conditions

Prematurity Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

29 week–37 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Monza Hospital, Monza, Lombardy, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Osteopathic manipulative treatment

Other

Patients from this group received osteopathic treatments twice a week for the entire length of stay in the unit.

Usual Care

Other

Patients from control group received standard care plus osteopathic evaluation only, according to the same schedule as the study group.

Primary outcomes

  1. Number of days of LOS

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Secondary outcomes

  1. pre-post difference in weight gain

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks

  2. number of episodes of vomit

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks

  3. days to full enteral feeding

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks

  4. NICU costs

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks

  5. number of episodes of regurgitation

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks

  6. number of episodes of stooling

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Sponsors and collaborators

Lead sponsor

European Institute for Evidence Based Osteopathic Medicine

Other

Collaborators

  • Italian Academy of Traditional Osteopathy - AIOT

Registry information

Official study title

Effectiveness Of Osteopathic Manipulative Treatment In Neonatal Intensive Care Units: A Multicenter Randomized Clinical Trial

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 20, 2012
Registry last updated
Apr 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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