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Birth Weight clinical trials

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NCT ID: NCT04002908 Completed - Pre-Term Clinical Trials

Low-birthweight Infant Feeding Exploration

LIFE
Start date: July 31, 2019
Phase:
Study type: Observational

Globally, 15% of all babies, amounting to 20 million infants each year, are born low birthweight (LBW), defined less than 2500 grams (5.5 lbs). Compared to normal weight infants, LBW infants are at higher risk of morbidity, mortality, and poor growth (Risnes et al 2011; Larroque et al 2001; WHO 2006). The main causes of LBW are preterm birth, intrauterine growth restriction (IUGR), or their combination. Unfortunately, there is a paucity of information around feeding practices and optimal feeding strategies for this population, particularly for LBW infants who struggle with breastfeeding or growth. This study hopes to address these gaps.

NCT ID: NCT03916159 Completed - Anemia Clinical Trials

Extrauterine Placental Transfusion In Neonatal Resuscitation Of Very Low Birth Weight Infants

EXPLAIN
Start date: May 1, 2019
Phase: N/A
Study type: Interventional

To investigate the effect of extrauterine placental transfusion (EPT) compared to delayed cord clamping (DCC) on the mean hematokrit on the first day of life in very low birth weight infants (VLBW) born by caesarian section. The investigators hypothesize that EPT provides higher blood volume during neonatal transition and improves neonatal outcome of VLBW infants.

NCT ID: NCT03886844 Completed - Weight Gain Clinical Trials

Growth and Weight Gain in ELBW Infants Fed an Exclusively Human Milk Based Diet With Prolacta®

Start date: December 2015
Phase:
Study type: Observational

Preterm infants are susceptible to postnatal growth restriction. Breast milk is the recommended source of nutrition for preterm infants. As preterm infants have enhanced nutritional requirements, multicomponent fortifiers are added to breast milk in order to establish adequate growth. Due to the various benefits of human milk feds to preterm infants, a human milk fortifier based on donor milk (Prolact+6 H2MF® Prolacta, City of Industry, California) has been developed. With this study, the investigators want to evaluate the effect of human milk fortification on weight gain in extremely low birth weight infants (ELBW, <1000g birth weight) in comparison to bovine fortification.

NCT ID: NCT03884322 Completed - Prematurity Clinical Trials

Self Regulated Physical Activity and Bone Growth Enhancement in Premature Infants

Start date: October 21, 2013
Phase: N/A
Study type: Interventional

Premature very low birth weight (VLBW) infants were placed in two groups matched for birth age. The control group received traditional joint compression exercises designed to decrease bone density loss. Exercises lasted approximately 10 minutes each day 5 days a week. The experimental group were placed in a "prepod", an elastic fabric pod shaped garment or sack on entry into the study and remained in the pod essentially 24 hours a day, with brief breaks for bathing, parental skin to skin experiences,etc. An ultrasound of the left tibia was done on entrance into the study at 31 to 32 weeks gestation and again at completion of the study 4 weeks later. Results showed that experimental infants in pods had slightly less bone density loss than their peers receiving traditional therapy. An incidental finding was that the experimental infants in pods had a significantly shorter length of stay.

NCT ID: NCT03880032 Completed - Anxiety Clinical Trials

Happy Mother-Healthy Baby: An Anxiety-focused Early Prenatal Intervention

HMHB
Start date: April 16, 2019
Phase: N/A
Study type: Interventional

In the proposed study the investigators will develop an early prenatal preventive intervention targeting anxiety and conduct a randomized controlled trial in Pakistan to test its efficacy in reducing generalized anxiety disorder and major depression in mothers in late pregnancy and the postnatal period. Investigators will evaluate the impact of the intervention on fetal and infant growth restriction as well as examine how the impact of the intervention is mediated (to elucidate mechanisms) and/or modified (to help optimize future adaptations of the program) by various social factors. A cost-effectiveness evaluation will shed light on the costs and benefits of intervention components in relation to outcomes, enabling policy-makers and public health planners to scale up this intervention according to resource budgeting requirements.

NCT ID: NCT03844204 Completed - Clinical trials for Neonatal Hypothermia

Effect of a Servo-control System on Heat Loss in Very Low Birth Weight Infants at Birth

SCOPRI
Start date: March 1, 2019
Phase: N/A
Study type: Interventional

Hypothermia in preterm infants during the immediate postnatal phase is associated with morbidity and mortality and remains an unresolved, worldwide challenge. A list of interventions, including adequate room temperature, use of infant warmers, polyethylene bags/wrap, pre-heated mattresses, caps and heated and humidified gases, to prevent thermal loss at birth in very preterm infants has been recommended, but a certain percentage of very preterm infants are hypothermic at the time of the neonatal intensive care unit (NICU) admission suggesting that further measures are needed. The thermal servo-controlled systems are routinely used in the NICU to accurately manage the patients' temperature, but their role during the immediate postnatal phase has not been previously assessed. We hypothesized that using a thermal servo-control system at delivery could prevent heat loss during this delicate phase and increase the percentage of very low birth weight infants (VLBWI) in the normal thermal range (temperature 36.5-37.5°C) at NICU admission. The aim of this study will be to compare two modes of thermal management (with and without the use of a thermal servo-controlled system) for preventing heat loss at birth in VLBWI infants.

NCT ID: NCT03841929 Completed - Clinical trials for Hemodynamic Instability

Multimodal Monitoring of Hemodynamics in Extremely Low Birth Weight Preterm Infant in a Canadian Tertiary Level Unit

MUSE
Start date: February 15, 2019
Phase: N/A
Study type: Interventional

Low blood pressure is a common problem in the premature newborn and can affect over 30% of all Extremely Low Gestational Age Neonates (ELGAN) babies delivered less than 28 weeks completed. Neonatal clinicians assess the hemodynamic status of the infant using clinical signs and physiological parameters including heart rate, blood pressure, capillary refill time, urine output and laboratory parameters (base deficit and lactate). While urine output and laboratory parameters do not provide real-time assessment of the hemodynamic status, heart rate and capillary refill time could be non-specific, inaccurate and observer-dependent, respectively. Blood pressure (BP) continues to be used as a common physiological marker for cardiovascular state in neonates.However, there is increasing amount of evidence that monitoring blood pressure alone is not enough to ensure adequate systemic and cerebral perfusion and oxygenation. Indeed, preterm babies may have "low blood pressure" triggering pharmacological treatment while still maintaining adequate systemic flow- especially cerebral and other organ perfusion as shown by other noninvasive measures like targeted neonatal echocardiography (TNE) and near infrared spectroscopy (NIRS). Using mean BP alone as the indication of treatment of neonatal cardiovascular compromise without taking into consideration the status of tissue perfusion may lead to unnecessary exposure of neonates to vasoactive medication. This medication can be potentially harmful to these extremely vulnerable patients. Analysis of a large neonatal database has demonstrated that treatment of hypotension was associated with an increase in serious brain injury. This held true even after the blood pressure was included in the regression mode, suggesting that it is treatment of hypotension, rather than the presence of hypotension which is harmful. The common interventions, fluid boluses followed by inotropes, could as well be harmful. Observational data has shown an association of fluid boluses with intracranial bleeding and in animal models intraventricular haemorrhage after hypotension can be induced by rapid volume infusion. Fluctuations in blood pressure when inotropes are introduced are well known and could also trigger haemorrhage. Current standard approaches to evaluation and treatment of transitional circulatory problems in the preterm infant may be harmful. Therefore it is essential that these approaches are adequately investigated. This research study is trying to find out if having a detailed hemodynamic understanding using a multimodal assessment consisting of Targeted Neonatal Echocardiogram, Cerebral NIRS and clinical-biochemical data, will result in less inotrope use in ELGAN population during the first 72hours of transitional period.

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: NCT03694613 Completed - Preterm Infant Clinical Trials

Utility of Placental/Umbilical Cord Blood in Early Onset Neonatal Sepsis in Very Low Birth Weight Infants

Start date: June 1, 2019
Phase: N/A
Study type: Interventional

This study evaluates the utility of placental/umbilical cord blood (PUCB) to perform the baseline workup testing for EONS in Very Low Birth Weight Infants: CBC (Complete Blood Count) with differential, Immature/Total ratio (I/T ratio), and blood culture along with CRP and IL-6 levels. A cohort (63 subjects) of preterm infants will be recruited. All the participants will be evaluated for sepsis using placental/umbilical cord blood (PUCB) and subject blood sample during the first 12 hours of life (after birth).

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.