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Premature BirthNCT05619224

Physiotherapy to Improve Feeding Skills in Preterm Infants

A study testing Neurodevelopmental stimulation + Oral stimulation and Oral stimulation in people with Premature Birth and Parenteral Nutrition, run by Universidad de Almeria at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 27 to 32 weeksHealthy volunteers can take part
What is being tested?
Neurodevelopmental stimulation + Oral stimulation and Oral stimulation
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteSpain
Study dates
1 Feb 2022to 25 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 27 to 32 weeks
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • Neurological disorders
  • Invasive mechanical ventilation
  • Congenital disorders
  • Necrotising enterocolitis
  • Metabolic diseases
  • Intraventricular hemorrhage grade 3-4
Show all 9Show fewer
  • Genetic disorders
  • Oral disorders that make this process difficult(cleft palate, cleft lip...)
  • Serious illnesses according to medical criteria

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • University Hospital Torrecardenas

    Almería, Almería, 04009

Other trials in Spain

About this study

Official title: Efficacy of a Physiotherapy Intervention 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.

Read more

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.

Being tested
Neurodevelopmental stimulation + Oral stimulation, Oral stimulation
Keywords
Premature Birth, Neurodevelopmental Disorders, NICU, Physical Stimulation
Medical subject headings
Premature Birth, Hyperphagia, Motor Disorders, Neurodevelopmental Disorders, Sucking Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neurodevelopmental stimulation + Oral stimulationOther

    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 stimulationOther

    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.

Study groups in NCT05619224
Study groupRoleWhat they receive
GEO+NExperimentalNeurodevelopmental stimulation intervention programme combined with an oral stimulation programme. They recives 10 sesions of 15 minutes of stimulation.
Receives: Other: Neurodevelopmental stimulation + Oral stimulation; Other: Oral stimulation
GEOExperimentalOral stimulation programme. They recives 10 sesions of 15 minutes of stimulation.
Receives: Other: Oral stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Transition time

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

    Measured: Two years

Secondary outcomes (9)

  1. Feeding evolution

    Total oral amount

    Measured: Two years

  2. OFEATINg (Oral FEeding Assessment in premaTure Infants)

    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.

    Measured: Two years

  3. Weight

    With a scale in grames

    Measured: Two years

  4. Height

    With a measuring tape in millimeters.

    Measured: Two years

  5. Head circumference.

    With a measuring tape in millimeters.

    Measured: Two years

  6. PERI

    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)

    Measured: Two years

  7. Gross Motor Skills

    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).

    Measured: Two years.

  8. Neuromotor Development

    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.

    Measured: Two years

  9. Neuromotor Development

    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).

    Measured: Two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2022
  2. Study start1 Feb 2022
  3. Primary completion28 Feb 2025
  4. Study completion25 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05619224
Sponsor's protocol ID
FiPrem
Status last verified
Mar 2025
First submitted
22 Oct 2022
Last updated
30 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data that support the findings of this study are available from the corresponding author upon reasonable request.

Publications

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

    PubMed 1720234

  • 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.

    PubMed 35551222

  • 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.

    PubMed 25279804

  • 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.

    PubMed 28537470

  • 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.

    PubMed 34384482

Questions about this trial

What is this clinical trial studying?

A study testing Neurodevelopmental stimulation + Oral stimulation and Oral stimulation in people with Premature Birth and Parenteral Nutrition, run by Universidad de Almeria at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Transition time (time frame: Two years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05619224, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.

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