NCT03911674

Brief Summary

Preterm infants with gestational age inferior to 34 weeks were included in the study. A prospective experimental group received the oral stimulation protocol and the effects of the intervention were compared with a historical control group that did not receive any oral stimulation intervention. The study hypothesis is that oral stimulation in preterm infants has beneficial effects on the feeding performance, the length of hospitalization and anthropometric variables, including weight at discharge, height at discharge and head circumference at discharge.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2017

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 11, 2019

Completed
Last Updated

April 11, 2019

Status Verified

April 1, 2019

Enrollment Period

7 months

First QC Date

March 31, 2019

Last Update Submit

April 9, 2019

Conditions

Premature InfantEating Disorder

Outcome Measures

Primary Outcomes (7)

  • Gestational age at the initiation of oral feeding

    Up to 46 weeks

  • Weight at discharge (g)

    Up to 46 weeks

  • Height at discharge (cm)

    Up to 46 weeks

  • Head circumference at discharge (cm)

    Up to 46 weeks

  • Days of enteral nutrition

    Up to 46 weeks

  • Gestational age at discharge (weeks)

    Up to 46 weeks

  • Total length of hospitalization

    Up to 46 weeks

Study Arms (2)

Oral stimulation

EXPERIMENTAL

Oral stimulation protocol: manual stimulation of the oral sucking

Other: Oral manual stimulation of feeding in preterm infants

Control

NO INTERVENTION

No intervention

Interventions

Oral manual stimulation of feeding in preterm infantsOTHER

Manual stimulation of the cheeks (internal and external), lips, gums, tongue and palate by finger-strokin.

Oral stimulation

Eligibility Criteria

AgeUp to 7 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Preterm infants with gestational age inferior to 34 weeks

You may not qualify if:

  • Instability caused by respiratory, cardiac or gastrointestinal issues
  • Orofacial malformations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CEU San Pablo University

Madrid, Madrid, 28668, Spain

Location

MeSH Terms

Conditions

Premature BirthFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2019

First Posted

April 11, 2019

Study Start

September 1, 2017

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

April 11, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)