Effects of the Application of PIOMI in the Oral Feeding of Premature
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age29-30
SponsorFundació Sant Joan de Déu
About this trial
The goal of this clinical trial is assess whether the application of the premature oral motor intervention (PIOMI) combined with the Newborn Individualized Developmental Care and Assessment Program (NIDCAP), allows withdrawal of the external feeding device with guarantees of the patient's nutritional status, determining breastfeeding rates at hospital discharge and swallowing safety earlier than if only the care activity corresponding to the NIDCAP model is carried out, as well as the applicability of this standardised protocol in the neonatal intensive care unit of a tertiary hospital.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Neonates born at the Sant Joan de Déu Hospital with a gestational age between 29-30 weeks carrying an external feeding device due to the difficulty of oral feeding and that the medical team in charge considers clinically stable.
Disqualifiers
Endotracheal intubation or high-flow ventilatory support.
Exclusive parenteral nutrition.
Hyporeactive due to the use of sedative drugs.
Condition of prematurity associated with other pathologies (syndromes, acquired brain damage, gastrointestinal malformations, airway and craniofacial malformations).
Trial design
Design model
Parallel
Treatments tested in this trial
Experimental group PIOMI
Other interventionA group treated with the application of the care model Newborn Individualized Development Care and Assessment Program (NIDCAP) in the Neonatal Intensive Unit Care (NICU)+PIOMI
Control group NIDCAP
Other interventionA group treated with the application of the care model Newborn Individualized Development Care and Assessment Program (NIDCAP) in the Neonatal Intensive Unit Care (NICU)
Treatment groups
35 Participants
are divided into 2 treatment groupsGroup A: Experimental Group PIOMIExperimental treatment 1 intervention
Group B: Control Group NIDCAPSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time to remove the external feeding device
To perform a proper calculation, the investigator must quantify the days of life in which the feeding device is placed and the date of effective removal
Time frame
Days of life of the baby when the external feeding device is removed assessed up to 30 daysSecondary outcomes
1
Volume of intake at discharge
To perform a proper calculation, the investigator must quantify the volumen of milk in millilitres from the day of device removal until hospital discharge.
Time frame
Milliliters that the baby take orally until the day of hospital discharge up to 4 weeks2
Hospitalization days
Quantify the days from birth to hospital discharge.
Time frame
Days that the premature baby remains hospitalized from birth to hospital discharge up to 12 weeks3
Breastfeeding patients after hospital discharge
Quantify the babies who perform Breastfeeding, Deferred breastfeeding or Artificial Breastfeeding according to the group assigned at discharge.
Time frame
Number of patients who are breast-feeding after hospital discharge up to 12 weeks4
Deferred breastfeeding patients after hospital discharge
Quantify the babies who perform Breastfeeding, Deferred breastfeeding or Artificial Breastfeeding according to the group assigned at discharge
Time frame
Number of patients who are Deferred breast-feeding after hospital discharge ,up to 12 weeksOther outcomes
1
Results of the items of the evaluation Neonatal Oral-Motor Assessment Scale (NOMAS)
The NOMAS tool consists of 29 items distributed in 3 domains: * Normal pattern: The range is from 27 to 40, with 27 being the lowest score and 40 being the highest score. * Disorganized pattern:The range is from 14 to 26, with 14 being the lowest score and 26 being the highest score. * Disfunctional pattern:The range is from 0 to 14, with 0 being the lowest score and 14 being the highest score. To achieve the feasibility of the evaluation tools Neonatal Oral-Motor Assessment Scale (NOMAS), the percentage of responses obtained will be taken into account. As a descriptive data analysis tool, the International Business Machines (IBM)software, Statistical Package for Social Sciences(SPSS) version 19.0.1 and variance analysis program(ANOVA), will be used in the pre- and post-test comparative data analysis.
Time frame
The researchers will administer Neonatal Oral-Motor Assessment Scale (NOMAS)last day of intervention(10 days)2
Results of the items of the evaluation Early Feeding Skills (EFS)
The EFSA tool consists of 19 items distributed in 5 domains: Regulation of breathing 5 items: The range is from 5 to 15 with 5 being the lowest score and 15 being the highest score Oromotor function 4 items: The range is from 4 to 12 with 4 being the lowest score and 14 being the highest score Swallowing-breathing coordination 4 items: The range is from 4 to 12 with 4 being the lowest score and 12 being the highest score Attention when taking 2 items and stability: The range is from 2 to 6 with 2 being the lowest score and 6 being the highest score Physiological 4 items: The range is from 4 to 12 with 4 being the lowest score and 12 being the highest score To achieve the feasibility of the evaluation tools EFS, the percentage of responses obtained will be considered. As a descriptive data analysis tool, Statistical package for the social sciences version 19.0.1 and variance analysis program, will be used in the pre- and post-test comparative data analysis.
Time frame
The researchers will administer (EFS)last day of intervention (10 days)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fundació Sant Joan de Déu
Lead sponsor
Sociedad Espanola de Gastroenterologia, Hepatologia y Nutricion Pediatrica
Collaborator
Nexe Foundation
Collaborator
University Ramon Llull
Collaborator
Borja Institute of Bioethics
Collaborator
Institut de Recerca Sant Joan de Déu
Collaborator
Source ClinicalTrials.gov