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Low Birth Weight clinical trials

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NCT ID: NCT03779737 Completed - Resistance Training Clinical Trials

Resistance and Aerobic Training, Relationship With Birth Weight in Colombian Children

SIMAC
Start date: February 1, 2016
Phase: N/A
Study type: Interventional

Background Risk factors for cardiometabolic diseases have their onset in infancy. Comorbidities such as overweight, abdominal obesity, hypertension, insulin resistance and elevated triglycerides have been observed in childhood with a tendency to persist into adult life. Furthermore, this situation has generated an increase in morbidity and mortality rates due to chronic non-communicable diseases. One approach to decrease the impact of cardiometabolic diseases is the intervention with exercise training (strength and aerobic capacity), where an important role of protein intake plays a role in influencing the performance of strength training, due to the greater utilization of low-energy protein compared to aerobic exercise. In children, a better tolerance was reported in muscle strength exercises, with at least one supervised training session per week with moderate intensity (20 minutes of physical activity). Currently, there is no consensus on the minimum time required to intervene and achieve significant changes in the metabolic profile of adolescents and children. Objective To evaluate the relationship between weight at birth and adaptations to aerobic exercise and muscular strength, and its effects on metabolic risk, body composition and physical capacity. Methodology An experimental study with individual analysis per participant would be perform. The sample will include a 12 to 17-year-old adolescent population. It will consist of two phases. The intervention will be based on moderate strength, power and resistance training programs, and/or moderate aerobic capacity exercise in circuit steps. The workouts will be done two times a week, approximately 30 to 40 minutes including warm-up, stretching and cooling. All participants personal and family history data would be collected and blood samples would be taken. Potential results Within the expected results, the protocol wants to implement a new methodology of physical capacity training. Furthermore, the protocol will evaluate if related cardiometabolic risk factors with the intervention would improve in target patients at risk of developing cardiometabolic diseases to identify them and prevent the occurrence of these pathologies in adult life.

NCT ID: NCT03689218 Completed - Stunting Clinical Trials

Evidence Generation Related to Stunting Prevention in Balochistan

Start date: August 15, 2018
Phase: N/A
Study type: Interventional

The World Food Programme (WFP) has signed MoU with Planning and Development Department of Balochistan in collaboration with Nutrition Cell and National Programme for Family Planning and Primary Health Care, Balochistan for the prevention of stunting. The project will utilize the window of opportunity (1000 days from conception to 2 years) for addressing stunting in children under-two years. Therefore project will recruit pregnant women during first trimester and newborns who delivered from recruited pregnant women will be followed until the age of 2 years. Children 6-12 months of age will be enrolled and followed until the age of two years. The interventions included nutritional supplements during pregnancy, lactation and for children during 6-24 months of age. The project will be implemented in Lady Health Workers (LHWs) covered areas of districts Pishin and Quetta, Balochistan.

NCT ID: NCT03533712 Completed - Prematurity Clinical Trials

Effect of a Fortified Balanced Energy-Protein Supplement on Birth Outcome and Child Growth in Houndé District, Burkina Faso.

MISAME-3
Start date: October 30, 2019
Phase: Phase 4
Study type: Interventional

The 2016 WHO antenatal care guidelines stated that pregnant women in undernourished populations should receive fortified balanced energy-protein (BEP) supplements to reduce the risk of stillbirth and small-for-gestational-age birth. However, acceptable supplements and delivery channels must be determined for different contexts. The present proposal therefore will 1) perform a formative study to identify the most suitable (acceptability and utilization) BEP supplement for pregnant women in rural Burkina Faso (phase 1) and 2) evaluate the efficacy of this supplement to improve birth weight, fetal and infant growth (phase 2). The nutritional composition of the BEP supplement was established during an expert convening at the BMGF in September 2016. Private sector partners will prepare the supplements in the selected forms with the recommended nutrient composition.

NCT ID: NCT03506698 Completed - Low Birth Weight Clinical Trials

Kangaroo Mother Care Implementation Research for Accelerating Scale-up

Start date: June 15, 2017
Phase:
Study type: Observational

The implementation research project aims to develop and evaluate models for scaling up KMC in health facilities across India and Ethiopia and thereby develop effective approaches to achieve high population coverage

NCT ID: NCT03419416 Completed - Low Birth-weight Clinical Trials

KMC Implementation Research for Accelerating Scale-up in Oromia Region, Ethiopia

KMC-Oromia
Start date: June 24, 2017
Phase:
Study type: Observational [Patient Registry]

The main objective is to implement Kangaroo Mother Care (KMC) at selected facilities in Addis Ababa and Oromia Regions to achieve high effective coverage in the catchment population.

NCT ID: NCT03405181 Completed - Infant Development Clinical Trials

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

Start date: January 12, 2018
Phase: N/A
Study type: Interventional

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).

NCT ID: NCT03154177 Completed - Preterm Birth Clinical Trials

Group Antenatal/Postnatal Care in Rwanda

PTBi Rwanda
Start date: May 15, 2017
Phase: N/A
Study type: Interventional

The focus of this work is to improve antenatal care (ANC) and postnatal care (PNC) at the health center level in five districts in Rwanda (Bugesera, Burera, Nyamasheke, Nyarugenge, and Rubavu). 36 health centers in these districts are included in this cluster randomized control trial (RCT) of group ANC and PNC care to measure this alternative model's effects on gestational age at birth, survival of preterm and low birth weight infants at 42 days of life, and ANC and PNC coverage. To improve antenatal assessment of gestational age, nurses will be trained in obstetric ultrasound at 18 health centers. These facilities will also incorporate pregnancy testing with urine dipstick to be performed by community health workers in charge of maternal health to facilitate early entry into ANC. This trial will test the hypothesis that women who participate in this alternative model of group ANC will experience increased gestational age at birth, as compared to women who receive standard focused ANC. This study is a collaboration with the University of Rwanda, the Rwandan Ministry of Health (MOH), the Rwanda Biomedical Center, and UCSF. The group care model used in this study is Rwanda-specific model developed by a Rwandan technical working group. The model includes an individual clinical visit for the first antenatal visit, followed by three group visits spaced about 8 weeks apart throughout pregnancy and a postnatal group visit at approximately 6 weeks after birth. Women will be grouped into stable groups of approximately 8-12 women with similar due dates. A community health worker (CHW) and a health center nurse will work together as co-facilitators to lead each of the groups. Each group visit includes clinical assessment, education, and treatments as appropriate for the women who attend. The model is founded on facilitative leadership of the groups, in which the co-facilitators allow women's experiences and interests to drive the content and women are encouraged to help one another cope with obstacles to optimal health. Facilitators will be supported by master trainers who will visit health centers to observe group sessions and offer supportive feedback. Data collected in this trial will include measures of the satisfaction of both women and providers with the group care, content of care differences between standard and group care, and perinatal outcomes such as gestational age at delivery and 42-day preterm and low birth weight infant survival.

NCT ID: NCT03137225 Terminated - Low Birth Weight Clinical Trials

Noninvasive NAVA Versus NIPPV in Low Birthweight Premature Infants

Start date: April 15, 2017
Phase: N/A
Study type: Interventional

The investigator hypothesizes that in very low birth weight infants who require respiratory support via noninvasive ventilation, that synchronizing the ventilator breath with the baby's breath using neurally adjusted ventilatory assist (NAVA) will reduce the number and/or severity of apnea/bradycardia/desaturation episodes compared to nasal intermittent positive pressure ventilation (NIPPV).

NCT ID: NCT03112018 Completed - PreTerm Birth Clinical Trials

Strengthening Facility-based Intrapartum/Immediate Newborn Care to Reduce Mortality of Preterm Infants in Migori County, Kenya and Busoga Region, Uganda

PTBi-KE-UG
Start date: October 1, 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether a combination of evidence-based strategies can improve intrapartum and newborn care in facilities to reduce mortality among preterm infants. This will be a cluster randomized implementation science study across 23 facilities in Eastern Uganda and Western Kenya. Selected interventions will be supported in facilities to measure impact during the study period. These interventions are: a) data strengthening and data use activities; b) implementation of a modified WHO Safe Childbirth Checklist with an emphasis on preterm labor and preterm babies; c) simulation-based provider training and mentoring on key existing evidence-based practices to improve newborn outcomes; d) support of Quality Improvement (QI) cycles to identify and resolve facility-specific issues and bottlenecks. A two-stage design will be used where all study facilities will receive some aspects of the intervention initially, namely data strengthening and the modified checklist. Subsequently, the remaining interventions (QI cycles and simulation training of providers) will be rolled out to a randomly selected half of the facilities in the first stage. At a second stage, the remaining half of the facilities will receive the remaining interventions.

NCT ID: NCT03020147 Completed - Low Birth Weight Clinical Trials

Low Birth Weight Follow-up

Start date: February 15, 2017
Phase:
Study type: Observational

The Randomized Control Trail included 4,172 low-birth weight children between February 2008 and September 2013 in Bissau. The children who were included in the RCT and who are living in the Bandim Health Project study area will be visited. The study assistants will ask about the health of the child and of both parents. Furthermore, Bacille Calmette-Guerin (BCG) scar status of both child and parents will be checked.