Clinical trial NCT05619224: Physiotherapy to Improve Feeding Skills in Preterm Infants
Official title: Efficacy of a Physiotherapy Intervention to Improve Feeding Skills in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Parenteral Nutrition
Motor Disorders
Neurodevelopmental Disorders
Sucking Behavior
Keywords: Premature Birth
Neurodevelopmental Disorders
NICU
Physical Stimulation
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
First posted: 2022-11-16
Enrollment: 56
Sex: ALL
Minimum age (years): 27
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Transition time
timeFrame: Two years
Secondary outcomes:
measure: Feeding evolution
timeFrame: Two years
measure: OFEATINg (Oral FEeding Assessment in premaTure Infants)
timeFrame: Two years
measure: Weight
timeFrame: Two years
measure: Height
timeFrame: Two years
measure: Head circumference.
timeFrame: Two years
measure: PERI
timeFrame: Two years
measure: Gross Motor Skills
timeFrame: Two years.
measure: Neuromotor Development
timeFrame: Two years
measure: Neuromotor Development
timeFrame: Two years
Other outcomes:
Locations:
city: Almería
country: Spain
facility: University Hospital Torrecardenas
Study officials:
References:
citation: Scheiner AP, Sexton ME. Prediction of developmental outcome using a perinatal risk inventory. Pediatrics. 1991 Dec;88(6):1135-43.
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.
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.
citation: 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.
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.