Clinical trial NCT04356807: Physical Therapy to Prevent Osteopenia in Preterm Infants
Official title: Effect of Physiotherapy on the Promotion of Bone Mineralization in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Bone Disease
Keywords: Premature Infant
Physical Therapy Modalities
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 101
Sex: ALL
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To determine whether reflex locomotion therapy is effective for the prevention of osteopenia in preterm infants and compare its effectiveness over other physiotherapeutic methods like passive joint mobilizations and massage

Detailed description: Premature infants have smaller and low bone mineralization compared with term infants bones, since 80% of calcium uptake occurs at the end of pregnancy. Passive Physiotherapy has been effective in the treatment of osteopenia. Active mobilizations implemented by the baby itself, may be more effective than passive, as they cause muscle contraction from the Central Nervous System (CNS). Reflex locomotion therapy (RLT), stimulates CNS causing muscle contraction so it may be effective in the treatment of osteopenia in premature.

Objectives: To determine whether RLT is effective for the prevention of osteopenia in preterm infants and compare its effectiveness over other physiotherapeutic methods.

Methodology: Our study is a multicentre randomized clinical trial, with 90 children less than 34 weeks of gestational age, divided into three treatment groups, one will receive RLT, another will be treated with passive joint mobilizations with articular pressure; and last one will be done massage techniques. The treatment will last for one month, for the three groups. We intend to measure changes in mineralization, bone formation, and bone resorption, and anthropometry.

Eligibility criteria: Inclusion Criteria:

* Preterm infants
* 26 to 34 weeks of gestational age
* Admitted in neonates
* Hemodynamically stable
* Complete enteral nutrition
* Parents or guardians signed an informed consent authorizing the participation of the baby in this study.

Exclusion Criteria:

* Neurological disorders
* Mechanical ventilation

  * Bronchopulmonary dysplasia
* Congenital malformations
* Metabolic diseases
* Genetic diseases
* Intraventricular hemorrhage III-IV,
* Diuretic medication or corticosteroids
* Bone fractures at the time of inclusion.

Primary outcomes:
measure: Change in Tibial Speed of Sound
timeFrame: Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment)
measure: Change in Serum biomarkers of Bone-specific phosphatase markers
timeFrame: Change measurement: Pre treatment (baseline), and after four weeks of treatment (end of the treatment)
measure: Change in Serum biomarkers of osteocalcin markers
timeFrame: Change measurement: Pre treatment (baseline), and after four weeks of treatment (end of the treatment)
measure: Change in Serum biomarkers of Beta-cross Laps.
timeFrame: Change measurement: Pre treatment (baseline), and after four weeks of treatment (end of the treatment)
measure: Change in Urine biomarkers of N-telopeptides from collagen bonds
timeFrame: Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment)
Secondary outcomes:
measure: Change in Height
timeFrame: Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment)
measure: Change in Weight
timeFrame: Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment)
measure: Change in Head circumference
timeFrame: Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment)
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Alicante
city: Almería
country: Spain
facility: Hospital Torrecárdenas de Almería
city: Murcia
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
Study officials:
affiliation: Universidad de Murcia
name: Galaad Torró-Ferrero, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vignochi CM, Miura E, Canani LH. Effects of motor physical therapy on bone mineralization in premature infants: a randomized controlled study. J Perinatol. 2008 Sep;28(9):624-31. doi: 10.1038/jp.2008.60. Epub 2008 Jul 17.
citation: Vignochi CM, Silveira RC, Miura E, Canani LH, Procianoy RS. Physical therapy reduces bone resorption and increases bone formation in preterm infants. Am J Perinatol. 2012 Sep;29(8):573-8. doi: 10.1055/s-0032-1310520. Epub 2012 Jul 6.
citation: Moyer-Mileur L, Luetkemeier M, Boomer L, Chan GM. Effect of physical activity on bone mineralization in premature infants. J Pediatr. 1995 Oct;127(4):620-5. doi: 10.1016/s0022-3476(95)70127-3.
citation: Shaw SC, Sankar MJ, Thukral A, Natarajan CK, Deorari AK, Paul VK, Agarwal R. Assisted Physical Exercise for Improving Bone Strength in Preterm Infants Less than 35 Weeks Gestation: A Randomized Controlled Trial. Indian Pediatr. 2018 Feb 15;55(2):115-120. Epub 2017 Dec 14.
citation: Giannantonio C, Papacci P, Ciarniello R, Tesfagabir MG, Purcaro V, Cota F, Semeraro CM, Romagnoli C. Chest physiotherapy in preterm infants with lung diseases. Ital J Pediatr. 2010 Sep 26;36:65. doi: 10.1186/1824-7288-36-65.
citation: El-shaarawy MK, Rahman SAA, Fakher M, El A, Salah WM. Effect of rolling on oxygen saturation and incubation period in preterm neonates with respiratory distress syndrome. Int J Dev Res. 2017;07(01):11319-11323.
citation: Sanz-Esteban I, Calvo-Lobo C, Rios-Lago M, Alvarez-Linera J, Munoz-Garcia D, Rodriguez-Sanz D. Mapping the human brain during a specific Vojta's tactile input: the ipsilateral putamen's role. Medicine (Baltimore). 2018 Mar;97(13):e0253. doi: 10.1097/MD.0000000000010253.
citation: Torro-Ferrero G, Fernandez-Rego FJ, Aguera-Arenas JJ, Gomez-Conesa A. Effect of physiotherapy on the promotion of bone mineralization in preterm infants: a randomized controlled trial. Sci Rep. 2022 Jul 8;12(1):11680. doi: 10.1038/s41598-022-15810-6.
citation: Torro-Ferrero G, Fernandez-Rego FJ, Jimenez-Liria MR, Aguera-Arenas JJ, Pinero-Penalver J, Sanchez-Joya MDM, Fernandez-Berenguer MJ, Rodriguez-Perez M, Gomez-Conesa A. Effect of physical therapy on bone remodelling in preterm infants: a multicenter randomized controlled clinical trial. BMC Pediatr. 2022 Jun 24;22(1):362. doi: 10.1186/s12887-022-03402-2.