NCT03405181

Effects of the Additional Weight on the Reaching Behavior of Pre Term Infants With Low Birth Weight

Completed NA Last updated 25 February 2019

What this trial tests

NA trial testing Training with additional weight in Preterm Infant in 66 participants. Completed in 15 September 2018.

Timeline

12 January 2018

Primary endpoint
15 September 2018

15 September 2018

Quick facts

Lead sponsor	University of Brasilia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	66
Start date	12 January 2018
Primary completion	15 September 2018
Estimated completion	15 September 2018
Sites	1 location across Brazil

Drugs / interventions tested

• Training with additional weight
• Training without additional weight

Conditions studied

• Preterm Infant — all drugs for Preterm Infant →
• Infant Development — all drugs for Infant Development →
• Low Birth Weight — all drugs for Low Birth Weight →

Sponsor

University of Brasilia

Who can join

Adults 6 Months to 7 Months, any sex, with Preterm Infant or Infant Development. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The effects of additional weight on early motor skills of infants have been increasingly studied. During the reaching behavior, the additional weight has been shown benefits in certain kinematic variables in full term and preterm infants. There is a growing interest in the study of populations at risk for motor development, especially considering interventions based on functional activities with the purpose of improving the neuromotor control, functional capacity and muscle strength. The aim of the present study is to investigate the effect of a functional training with additional weight in the reaching behavior of preterm infants with low birth weight and to compare the effects with a full term population. A controlled and randomized trial will be carried out with full term infants of adequate birth weight and preterm infants with low birth weight at 6 months of chronological or corrected age. The participants will be recruited by convenience from the charts of a Public Hospital. Participants will be randomly allocated into four groups: 1) adequate weight placebo group (AWPG); 2) adequate weight intervention group (AWIG); 2) low weight placebo group (LWPG) and 4) low weight intervention group (LWIG). . The assessor will be blinded (no knowledge of groups allocation). All infants will undergo a training program of eight sessions (2x/week; 4 weeks). The AWIG and LWIG will receive the training with an additional weight (characterized by a bracelet with a weight of 20% of the mass of the upper limbs)and the AWPG and LWPG will receive the same training, however, without the additional weight (only the bracelets).. All infants will be assessed in three different moments: 1) Pre-intervention: baseline, before the start of the intervention program; 2) Post-intervention: evaluation performed after the end of the program; and 3) Follow-up: evaluation performed seven days after the post-intervention assessment. The following kinematic dependent variables will be calculated: straightness index, mean velocity and motion units and electromyographic variables: pattern of activation and recruitment of muscle fibers - Biceps brachialis, Triceps brachialis, Deltoid and Pectoralis Major muscles; co-activation between biceps and triceps. The Qualisys Track Manager (QTM) and a wireless surface electromyography with 8-channels will be used. If normality assumptions are met, a mixed 2X2 ANOVA with repeated measures will be applied, in order to verify differences between the intervention programs, considering the dependent variables. Otherwise, non-parametric procedures of the same nature will be adopted. The significance will be set at 5% (P\<0.05).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.