NCT02146677

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 26, 2014

Completed
6 days until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

February 13, 2015

Status Verified

February 1, 2015

Enrollment Period

1 year

First QC Date

May 20, 2014

Last Update Submit

February 12, 2015

Conditions

Prematurity

Keywords

prematuritynewbornspaincost

Outcome Measures

Primary Outcomes (1)

  • changes from baseline in pain using Premature Infant Pain Profile (PIPP)

    baseline and end of hospitalization, average length of hospitalization expected 4 weeks

Secondary Outcomes (1)

  • Number of days of length of stay

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

Other Outcomes (1)

  • Neonatal intensive care unit cost

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

Study Arms (3)

Sham

OTHER

newborns will be osteopathically evaluated and softly touched

Other: Sham therapyOther: Usual care

Usual care

OTHER

newborns will be undergone usual routine neonatology care

Other: Usual care

OMT

OTHER

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

Other: Osteopathic manipulative treatmentOther: Usual care

Interventions

Osteopathic manipulative treatmentOTHER
OMT
Sham therapyOTHER
Sham
Usual careOTHER
OMTShamUsual care

Eligibility Criteria

Age26 Weeks - 37 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pescara Civil Hospital

Pescara, PE, 65100, Italy

RECRUITING

Related Publications (1)

  • Cerritelli F, Cicchitti L, Martelli M, Barlafante G, Renzetti C, Pizzolorusso G, Lupacchini M, D'Orazio M, Marinelli B, Cozzolino V, Fusilli P, D'Incecco C. Osteopathic manipulative treatment and pain in preterms: study protocol for a randomised controlled trial. Trials. 2015 Mar 8;16:84. doi: 10.1186/s13063-015-0615-3.

    PMID: 25872943DERIVED

MeSH Terms

Conditions

Premature BirthPain

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Central Study Contacts

Francesco Cerritelli, DO

CONTACT

+393394332801francesco.cerritelli@ebom.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2014

First Posted

May 26, 2014

Study Start

June 1, 2014

Primary Completion

June 1, 2015

Study Completion

September 1, 2015

Last Updated

February 13, 2015

Record last verified: 2015-02

Locations

IT(1)