NCT04290338

Brief Summary

Randomized controlled clinical trial aimed at evaluating the effects of the "Premature infant oral motor intervention" method on the oral feeding skills of the premature infants.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

February 28, 2020

Status Verified

February 1, 2020

Enrollment Period

5 months

First QC Date

February 24, 2020

Last Update Submit

February 27, 2020

Conditions

Feeding Disorder Neonatal

Outcome Measures

Primary Outcomes (1)

  • Mean volume

    Mean volume of oral intake

    7 days

Secondary Outcomes (4)

  • feeding efficiency

    3 days

  • achievement of full oral feeding

    6 moths

  • hospital stay time

    6 months

  • transition time

    6 months

Study Arms (2)

PIOMI Group

EXPERIMENTAL

Patients in this group will receive the intraoral and extraoral stimulations provided by the PIOMI protocol. These stimulations will last 5 minutes and will be performed once a day for 7 consecutive days for each patient.

Other: PIOMI

Control Group

NO INTERVENTION

Patients in this group will receive classic care.

Interventions

PIOMIOTHER

Intraoral and extraoral stimulation.

PIOMI Group

Eligibility Criteria

Age25 Weeks - 33 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • gestational age at birth between 25-33 weeks;
  • clinical stability;
  • possible presence of nasogastric or oro-gastric tube;
  • non-invasive respiratory support (oxygen, high flows)

You may not qualify if:

  • gestational age \<25 weeks or\> 33 weeks
  • absence of clinical stability
  • invasive respiratory support (CPAP)
  • previous surgical interventions
  • ongoing infections
  • congenital and / or chromosomal diseases
  • brain, metabolic, cardiac, gastrointestinal diseases
  • presence of bronchopulmonary dysplasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Odoardo Picciolini

    Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    STUDY DIRECTOR

Central Study Contacts

Odoardo Picciolini, physiatrist

CONTACT

0255034354odoardo.picciolini@policlinico.mi.it

Matteo Porro, physiatrist

CONTACT

0255034353matteo.porro@policlinico.mi.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: RCT characterized by the comparison between two groups (treated / untreated)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2020

First Posted

February 28, 2020

Study Start

March 1, 2020

Primary Completion

August 1, 2020

Study Completion

September 1, 2020

Last Updated

February 28, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will share

all collected IPD may result in a publication.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
1 year