Skip to main content
OpenTrials
Completed

NCT Number: NCT05619224

Physiotherapy to Improve Feeding Skills in Preterm Infants

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Premature Birth Behavior Female Urogenital Diseases and Pregnancy Complications Hyperphagia Mental Disorders Motor Disorders Neurodevelopmental Disorders Obstetric Labor Complications Obstetric Labor, Premature Parenteral Nutrition Pathological Conditions, Signs and Symptoms Pregnancy Complications Signs and Symptoms Signs and Symptoms, Digestive Sucking Behavior Urogenital Diseases

Age range

27 week–32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Torrecardenas

Almería, 04009, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Transition time

    Time frame: Two years

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

Secondary outcomes

  1. Feeding evolution

    Time frame: Two years

    Total oral amount

  2. OFEATINg (Oral FEeding Assessment in premaTure Infants)

    Time frame: Two years

    To assess the ability for oral feeding. This scale was developed in two phases, the first phase being the design and construction of its items, and the second phase consisted of the analysis of the reliability and validity of this scale to through a cross-sectional study conducted in 2016/2017.

    The Oral FEeding Assessment in premaTure Infants may help clinicians to evaluate oral feeding readiness and oral feeding success, defned as the infant's ability to maintain physiologic stability (Alonso-Fernandez et al., 2022) The total score of the OFEATINg scale is the sum of the scores of all the items, with a minimum score of 13 and a maximum of 52, with a higher score reflecting greater readiness for oral feeding.

  3. Weight

    Time frame: Two years

    With a scale in grames

  4. Height

    Time frame: Two years

    With a measuring tape in millimeters.

  5. Head circumference.

    Time frame: Two years

    With a measuring tape in millimeters.

  6. PERI

    Time frame: Two years

    With the hospital discharge report we will be able to carry out the perinatal risk inventory (PERI) obtaining a numerical value that estimates the level of biological risk of the baby.

    Considering: low risk in scores from 0 to 6, moderate from 7 to 9 and high 10 or more.

    (Scheiner et al,. 1991)

  7. Gross Motor Skills

    Time frame: Two years.

    In order to assess the quality of gross motor skills in the motor development of the baby we use the AIMS scale (Alberta Infant Motor Scale). The AIMS is an observational scale created by Canadian researchers to assess the motor development of children from birth to the acquisition of walking. Contains 58 items that assess the integrity and control of the antigravity muscles during different motor skills in prone position, supine position, sitting and standing(de Albuquerque et al, 2015).

  8. Neuromotor Development

    Time frame: Two years

    To know the motor development and cognitive development and language.

    The Bayley ScaleIII scale is the most used tool to assess development, its main objective is to identify children with a developmental delay and provide information for plan of intervention. It is composed of 6 scales that allow assessing at the level of the cognitive, linguistic, motor, social-emotional, adaptive, and behavior of children between 1 and 42 months (de Albuquerque et al, 2018).

    With this scale we can determine the percentile the child has in each area of development, with a higher score reflects greater capabilities.

  9. Neuromotor Development

    Time frame: Two years

    With the observation and analysis of the General Movements, you can get a lot of information about the situation of the child, allowing prognostic data to be provided to health professionals and family. The main objective of the GM's is to detect early the appearance of abnormal movements and predict possible cerebral palsy (Seesahai et al., 2021).

Sponsors and collaborators

Lead sponsor

Universidad de Almeria

Other

Registry information

Official study title

Efficacy of a Physiotherapy Intervention to Improve Feeding Skills in Preterm Infants

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 16, 2022
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.