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Enrolling By Invitation
NCT05619224
Physiotherapy to Improve Feeding Skills in Preterm Infants
Conditions: Premature Birth, Parenteral Nutrition, Motor Disorders, Neurodevelopmental Disorders, Sucking Behavior
Sex: All
Ages: 27 Weeks – 32 Weeks
Healthy volunteers: 1
Phase: NA
Enrollment: 76
Sponsor: Universidad de Almeria
Location: Spain
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 nutritionExclusion Criteria:Neurological disordersInvasive mechanical ventilationCongenital disordersNecrotising enterocolitisMetabolic diseasesIntraventricular hemorrhage grade 3-4Genetic disordersOral disorders that make this process difficult(cleft palate, cleft lip...)Serious illnesses according to medical criteria
Source: ClinicalTrials.gov (NCT05619224). StuddyBuddy aggregates publicly available trial information.