Physiotherapy to Improve Feeding Skills in Preterm Infants

NCT05619224 | Completed DMC

• 1 other identifier: FiPrem
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

INTRODUCTION: Suction problems are very common in premature children due to a lack of maturation and orofacial control, the manifestation of a low muscle tone and the incoordination during sucking-swallow-breathe. In addition, there are some problems in different systems that get it worse. AIM: compare oral stimulation programme with a neurodevelopmental stimulation intervention programme combined with an oral stimulation programme, evaluating its effectiveness on feeding development, neuromotor development and other aspects of development. METHODOLOGY: we proposed a prospective parallel group clinical trial with two randomized and independent experimental groups. All preterm infants born between 2022-2023 at University Hospital Torrecárdenas, with nasogastric tube and gestational age between 27-32 weeks will be included. EXPECTED BENEFITS: to have better results when the preterm infant is approached globally, also considering the postural situation of the preterm infant. In addition, it is expected that the development of children treated by combining oral stimulation with neurodevelopmental stimulation will be equated or close to healthy and born-to-term child. RESULTS APPLICABILITY: Improved eating performances will reduce length of hospital stay as well as a greater autonomy improving family situation. It will also allow the reduction of hospital costs and the creation of a new way to attend this problem in preterm children.

Conditions

Premature Birth; Parenteral Nutrition; Motor Disorders; Neurodevelopmental Disorders; Sucking Behavior

Keywords

Premature Birth; Neurodevelopmental Disorders; NICU; Physical Stimulation

Outcome Measures

Primary Outcomes (1)

• Transition time

  The transition time from tube to oral feeding. To complete this, the baby has to feed independently during two consecutive days.

  Two years

Secondary Outcomes (9)

• Feeding evolution

  Two years

• OFEATINg (Oral FEeding Assessment in premaTure Infants)

  Two years

• Weight

  Two years

• Height

  Two years

• Head circumference.

  Two years

Study Arms (2)

GEO+N

EXPERIMENTAL

Neurodevelopmental stimulation intervention programme combined with an oral stimulation programme. They recives 10 sesions of 15 minutes of stimulation.

Other: Neurodevelopmental stimulation + Oral stimulation; Other: Oral stimulation

GEO

EXPERIMENTAL

Oral stimulation programme. They recives 10 sesions of 15 minutes of stimulation.

Other: Oral stimulation

Interventions

Neurodevelopmental stimulation + Oral stimulation OTHER

Neurodevelopmental intervention seeks to reduce abnormal postures and movement patterns in premature infants, allowing them to experience physiological postures in flexion and receive sensory stimulation. To this is added oral stimulation. These stimulations are performed on alternate days.

GEO+N

Oral stimulation OTHER

This intervention consists of performing a sensorimotor stimulation of oral structures: stimulating for 7 minutes perioral structures( cheeks, lips and jaw)intraoral structures for 5 minutes and in the last 3 minutes non-nutritive suction stimulation with pacifier or finger.

GEO; GEO+N

Eligibility Criteria

• Age: 27 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Premature infants with a gestational age between 27 and 32 weeks, with an adequate weight for their gestational age, admitted to the unit of Neonatology, hemodynamically stable and with enteral nutrition

You may not qualify if:

• Neurological disorders
• Invasive mechanical ventilation
• Congenital disorders
• Necrotising enterocolitis
• Metabolic diseases
• Intraventricular hemorrhage grade 3-4
• Genetic disorders
• Oral disorders that make this process difficult(cleft palate, cleft lip...)
• Serious illnesses according to medical criteria

Sponsors & Collaborators

• Universidad de Almeria: lead

Study Sites (1)

University Hospital Torrecardenas

Almería, Almería, 04009, Spain

Location

Related Publications (5)

• Scheiner AP, Sexton ME. Prediction of developmental outcome using a perinatal risk inventory. Pediatrics. 1991 Dec;88(6):1135-43.

  PMID: 1720234 BACKGROUND

• Alonso-Fernandez S, de Liria CRG, Lluch-Canut T, Poch-Pla L, Perapoch-Lopez J, Juve-Udina ME, Martinez-Momblan MA, Hurtado-Pardos B, Roldan-Merino JF. Psychometric properties of the oral feeding assessment in premature infants scale. Sci Rep. 2022 May 12;12(1):7836. doi: 10.1038/s41598-022-11521-0.

  PMID: 35551222 BACKGROUND

• de Albuquerque PL, Lemos A, Guerra MQ, Eickmann SH. Accuracy of the Alberta Infant Motor Scale (AIMS) to detect developmental delay of gross motor skills in preterm infants: a systematic review. Dev Neurorehabil. 2015 Feb;18(1):15-21. doi: 10.3109/17518423.2014.955213. Epub 2014 Oct 3.

  PMID: 25279804 BACKGROUND

• Albuquerque PL, Guerra MQF, Lima MC, Eickmann SH. Concurrent validity of the Alberta Infant Motor Scale to detect delayed gross motor development in preterm infants: A comparative study with the Bayley III. Dev Neurorehabil. 2018 Aug;21(6):408-414. doi: 10.1080/17518423.2017.1323974. Epub 2017 May 24.

  PMID: 28537470 BACKGROUND

• Seesahai J, Luther M, Church PT, Maddalena P, Asztalos E, Rotter T, Banihani R. The assessment of general movements in term and late-preterm infants diagnosed with neonatal encephalopathy, as a predictive tool of cerebral palsy by 2 years of age-a scoping review. Syst Rev. 2021 Aug 12;10(1):226. doi: 10.1186/s13643-021-01765-8.

  PMID: 34384482 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Hyperphagia; Motor Disorders; Neurodevelopmental Disorders; Sucking Behavior

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 22, 2022
• First Posted: November 16, 2022
• Study Start: February 1, 2022
• Primary Completion: February 28, 2025
• Study Completion: March 25, 2025
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will become available for one year once the study is finished
• Access Criteria: Reasonable request to reproduce the intervention performed on this study

Locations

ES (1)