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Birth Weight clinical trials

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NCT ID: NCT05311540 Completed - Preterm Infant Clinical Trials

Zinc Supplementation In Very Low Birth Weight Infants-A Randomised Controlled Trial

Start date: March 14, 2014
Phase: Phase 4
Study type: Interventional

- Zinc (Zn) is a structural component of human body and is a crucial element for a wide variety of cascades that take place in almost all organ systems. - Due to many reasons, preterm infants are generally believed to be naturally in a negative Zn balance during the early periods of life. - Regulation of intestinal Zn absorption of preterms is unrelated to infant's Zn status. - There still is a lack of knowledge in the possible relation of Zn deficiency and development of NEC and/or feeding intolerance in preterm infants. - Even if Zn is studied as an adjunct treatment for neonates and young infants with sepsis and found to reduce treatment failure in these high risk population, data in preventing infectious diseases in preterm infants is still lacking.

NCT ID: NCT05308134 Recruiting - Clinical trials for Very Low Birth Weight Infant

Individualized Fortification of Human Milk for Infants Born ≤ 1250 g (MaxiMoM-InForM)

Start date: November 11, 2021
Phase: N/A
Study type: Interventional

Very low birth weight infants have increased nutritional needs. Extra nutrients are added to their human milk feeds to help improve their nutritional status, growth and neurodevelopment. Standard fortification of human milk is routine in most neonatal units in North America, but despite the added nutrients, infants are often discharged from hospitals with poor growth, and their neurodevelopment remains suboptimal. Two individualized fortification methods, target and BUN adjustable, have been proposed to improve the nutrient supply to infants. However, there is currently insufficient evidence to support the implementation of individualized fortification or one method over the other. Therefore, this study will randomly assign very low birth weight infants to receive feeds fortified according to standard, target or BUN adjustable fortification methods until 36 weeks gestational age or hospital discharge whichever occurs first. Feedings will be prepared in milk preparation rooms to ensure caregivers and outcomes assessor remain blinded to feeding allocation. Growth, morbidities, and nutrient intakes will be determined throughout hospitalization and skinfolds assessed at 36 weeks. At 4 months CA, growth and body composition will be determined by air displacement plethysmography and processing speed by electroencephalography on a subset of infants. Neurodevelopment will be assessed using the Bayley Scales of Infant and Toddler Development, at 18-24 months CA.

NCT ID: NCT05274386 Recruiting - Clinical trials for Very Low Birth Weight Infant

Evaluation of the Impact of SpO2 Averaging Time on Performance of an Automatic FiO2 Control System: a Randomized Study

Start date: February 17, 2022
Phase: N/A
Study type: Interventional

The aim of the study is to determine the preferred oximeter averaging setting during automated control of FiO2 (A-FiO2) in infants receiving respiratory support and supplemental oxygen.

NCT ID: NCT05251441 Active, not recruiting - Premature Clinical Trials

The Effect of Time to Start Breast Milk Fortifiers on Neonatal Outcomes in Very Low Birth Weight Premature Infants.

Start date: July 1, 2021
Phase: N/A
Study type: Interventional

In the study, very low birth weight babies born in our hospital will be randomized in the closed envelope method, and breast milk fortifier will be started when 50 ml/kg/day breastfeeding volume is reached in one group, and breast milk enrichment will be started when 100 ml/kg/day enteral feeding is reached in the other group. In the study, the babies in these two groups will be compared by making early (nutrition characteristics and premature morbidity) and long-term follow-ups. In this study, a 30% reduction in the transition time to full enteral nutrition between the groups corresponds to a difference of approximately 5 days. In our study, the sample size was determined as at least 78 patients in each group, with a margin of error of 0.05 and a power of 80% to show the 5-day difference between the groups.

NCT ID: NCT05243537 Enrolling by invitation - Preterm Birth Clinical Trials

QTc Intervals in Former Preterm/Extreme Low Birth Weight Infants: a Pooled Study Proposal

Start date: January 1, 2023
Phase:
Study type: Observational

Pooling effort to collect previously reported data on QTc time in former preterm neonates, and compare these data to controls. At present and based on a recently conducted systematic search, there are conflicting data on the potential QT interval prolongation (all Bazett) in former extreme low birth weight (ELBW, <1000 g) infants or preterms. Consequently, if investigators truly want to assess the presence or absence of either a difference or a prolongation of QTc intervals in this specific population, pooling of published data is likely the most effective approach (potential number of cases = 24 + 49 + 93 = 166; potential number of controls in the same studies = 24 + 53 + 87 = 164), preferably based on individual data. Although the sample is to a large extent pragmatic (as available), the investigators hereby aim to target the 5 ms QTc prolongation applied by the authorities (FDA, EMA) in paired healthy adult volunteer studies as 'golden' standard as primary outcome variable [EMA guideline, FDA guidance].

NCT ID: NCT05224921 Completed - Clinical trials for VLBW - Very Low Birth Weight Infant

Peripherel Perfusion Index to Predict Sepsis in Very Low Birth Weight Infants

Start date: January 1, 2022
Phase:
Study type: Observational

To explore the predictive value of peripheral perfusion index in late onset sepsis of very low birth weight infants , obtain the threshold by observing the perfusion index of very low birth-weight infants within one month after birth, this value can be used as a threshold to predict late onset sepsis in very low birth weight infants.

NCT ID: NCT05217199 Completed - Infant Development Clinical Trials

The Prechtl's General Movement Assessment, Hammersmith Infant Neurological Examination and Sensory Profile-2

highrisk
Start date: April 15, 2022
Phase:
Study type: Observational

In the Neonatal Intensive Care Unit (NICU), infants encounter many sensory stimuli (excessive noise, bright lights, painful medical applications, etc.) that are not present in the uterus. During the critical period of brain development, this sensory overload affects the physiological responses of infants; It can lead to sensory processing problems by causing negative changes in motor, neurological and sensory development. Sensory processing was explained by Dunn as the emergence of appropriate reactions and behaviors in neurological processes in which visual, auditory, tactile, oral, olfactory, vestibular, proprioceptive and kinesthetic inputs are regulated.

NCT ID: NCT05217186 Completed - Cerebral Palsy Clinical Trials

Associations Between Early Neonatal Neuroimaging, Hammersmith Infant Neurological Examination and General Movements

highrisk
Start date: September 15, 2020
Phase:
Study type: Observational [Patient Registry]

High risk infant is defined as infant with a negative history of environmental and biological factors, which can lead to neuromotor development problems. It is a heterogeneous group of premature infants born under thirty-seven weeks of age, with infants with low birth weight, term or developmental retardation for various reasons. Therefore, preterm infants with low birth weight can survive with a neurological sequelae such as cerebral palsy (CP), epilepsy, hearing and vision loss, mental retardation, speech and speech problems, and learning difficulties. The clinical diagnosis of CP, which can be observed in high-risk infants, is based on the combination of some neuroimaging and neurological examinations and assesments like neonatal imaging, general movements (GMs) and Hammersmith Infant Neurological Examination (HINE).

NCT ID: NCT05217056 Completed - Cerebral Palsy Clinical Trials

Associations Between General Movements Assessments and Cognitive Development

GMs
Start date: August 1, 2020
Phase:
Study type: Observational [Patient Registry]

High risk infant is defined as infant with a negative history of environmental and biological factors, which can lead to neuromotor development problems. It is a heterogeneous group of premature infants born under thirty-seven weeks of age, with infants with low birth weight, term or developmental retardation for various reasons. Therefore, preterm infants with low birth weight can survive with a neurological sequelae such as cerebral palsy (CP), epilepsy, hearing and vision loss, mental retardation, speech and speech problems, and learning difficulties. The clinical diagnosis of CP and learning diffuculties which can be observed in high-risk infants, is based on the combination of some neurological and clinical signs.

NCT ID: NCT05203900 Completed - Clinical trials for Low Birth Weight Infants

The Influence by Dietary Human Milk Oligosaccharide in Low Birth Weight Infants

Start date: December 13, 2021
Phase: N/A
Study type: Interventional

This study aims to investigate the concentration of various growth factors and cytokines in blood, and to examine the gut microbiota of low birth weight infants fed with formulas with or without Human Milk Oligosaccharide (HMO) supplement. Eligible low birth weight infants are allocated to two groups, Investigational formula (with HMO) or Control formula (without HMO). The subjects are taking the assigned formula when they need to be supplemented with formula. After the informed consent was obtained and eligibility was confirmed, the intervention period begins, and ends at the one-month-old medical check-up with the assessment of the various blood growth factors and cytokines, and the gut microbiota.