Physiotherapy to Improve Feeding Skills in Preterm Infants

Premature Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05619224
• Other study ID #: FiPrem
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: February 28, 2025

Study information

• Verified date: March 2024
• Source: Universidad de Almeria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 76
• Est. completion date: February 28, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 27 Weeks to 32 Weeks

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Neurodevelopmental stimulation + Oral stimulation
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
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.

Locations

Country	Name	City	State
Spain	University Hospital Torrecardenas	Almería

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Almeria

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Feeding evolution	Total oral amount	Two years
Secondary	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.	Two years
Secondary	Weight	With a scale in grames	Two years
Secondary	Height	With a measuring tape in millimeters.	Two years
Secondary	Head circumference.	With a measuring tape in millimeters.	Two years
Secondary	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)	Two years
Secondary	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).	Two years.
Secondary	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.	Two years
Secondary	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).	Two years