View clinical trials related to Premature Birth.
Filter by:Preterm infants (i.e. born before 37 completed weeks of pregnancy) often require additional care and are admitted to neonatal units. Readiness for discharge home typically requires a level of physiological maturity, such that an infant is: 1) able to breathe spontaneously without additional support; 2) able to maintain body temperature; 3) able to take all nutritional requirements orally; 4) weighs ≥1700 grams and is consistently gaining weight. Staying in the hospital longer than necessary can be detrimental to infants, stressful for families, and costly to the NHS. Reducing the length of stay by just one day would be meaningful to parents and could save the UK National Health Service (NHS) almost £25million per year. Currently little is known about whether, how long and why preterm infants stay in hospital beyond the point at which they are physiologically ready for discharge. This study will use data from babies' medical records from the whole of England and Wales to identify the age and postmenstrual age when preterm infants reach each of the physiological barriers to discharge and identify which physiological discharge barrier requires preterm infants to remain in hospital the longest. The study will quantify the difference between the time preterm infants become physiologically ready for discharge and actual discharge home and describe factors associated with extended stays.
The goal is to demonstrate the relationship of the circulating pool of T-regulatory lymphocytes in the mother's peripheral blood with populations in the placentas and to compare with controls, what is the difference in the expression of individual regulatory molecules of T-regulatory lymphocytes according to new paradigms. The proportional and functional characteristics of T-regulatory lymphocytes will be correlated with the composition of the intestinal and vaginal microbiota.
Previously, the investigators showed that preterm newborns are exposed chronically to very low radiofrequency levels in average while hospitalized in NICUs. Most of the infants were nevertheless frequently exposed to transient values above 1 V/m. The investigators also showed that an increase in RF exposure is likely to alter the activity of some neurophysiological functions and their regulatory systems in preterm newborns. The investigators hypothesize that above results are extremely specific to the location of the previous study and may be different in other NICU environments. This study will aim at quantifying RF levels to which preterm newborns are exposed during their stay in several NICUs spread across the French territory, and assessing its impact on the central and peripheral nervous systems. The first step of this study will be to quantify the precise, continuous and individual levels of daily RF exposure to which each recruited neonate is subjected during his stay in the different NICUs from birth to 1 week postnatal life. Infants' clinical data (medical history, nutrition, morphology...) will also be continually monitored. At 1 week postnatal life, the investigators will investigate cerebral activity (EEG) and autonomic nervous system activity (ECG, heart rate variability). The impact of RF will be evaluated by analyses of the relationship between exposure levels and the various parameters extracted from the neurophysiological investigation phase.
Before birth, the baby's lungs are filled with fluid and babies do not use the lungs to breathe, as the oxygen comes from the placenta. As delivery approaches, the lungs begin to absorb the fluid. After vaginal delivery, the umbilical cord is clamped and cut after a delay that allows some of the blood in the umbilical cord and placenta to flow back into the baby. Meanwhile, as the baby breathes for the first time, the lungs fill with air and more fluid is pushed out. However, it does not always work out that way. A baby born prematurely may have breathing problems because of extra fluid staying in the lungs related to the immaturity of the lung structure. Thus, the baby must breathe quicker and harder to get enough oxygen enter into the lungs. The newborn is separated from the mother to provide emergency respiratory support. Although the baby is usually getting better within one or two days, the treatment requires close monitoring, breathing help, and nutritional help as the baby is too tired to suck and swallow milk. Sometimes, the baby cannot recover well and show greater trouble breathing needing intensive care. This further separates the mother and her baby. A possible mean to help the baby to adapt better after a premature birth while staying close to the mother is to delay cord clamping when efficient breathing is established, either spontaneously or after receiving breathing help at birth. In this study, we intend to test this procedure in moderate or late preterm infants and see whether the technique helps the baby to better adapt after birth and to better initiate a deep bond with the mother.
Globally, over 15 million neonates are born preterm each year. They account for approximately 30% of global neonatal deaths and 19% of total neonatal deaths in Bangladesh. They usually die because they cannot maintain normal temperature due to their weight, immature skin and underdeveloped thermal regulatory capacity of the brain. Maintaining continuous Kangaroo Mother Care (KMC) for at least 16-20 hours/day, is sometimes not feasible for mothers or caregivers. In addition, we also have the challenge of keeping preterm or low birthweight (LBW) neonates warm during transportation. The scientists at icddr,b, Johns Hopkins University, and George Mason University developed the thermal jacket for keeping preterm or LBW neonate warm. We have already completed the laboratory trial on mannquins and clinical safety trial among preterm or LBW neonates. Now, we propose to build on our previous work by systematically testing the effectiveness trial of the 'thermal jacket' among preterm or LBW neonates at clinical settings. Hypothesis: Thermal jacket can increase the rate of euthermia among the preterm or LBW neonates in the selected health facilities in Bangladesh. Objectives: The aim of this study is to test whether the thermal jacket can attain and maintain euthermia of preterm or LBW neonates in clinical settings of Bangladesh.
Globally, over 15 million neonates are born preterm each year. They account for approximately 30% of global neonatal deaths and 19% of total neonatal deaths in Bangladesh. They usually die because they cannot maintain normal temperature due to their weight, immature skin and underdeveloped thermal regulatory capacity of the brain. Maintaining continuous KMC for at least 16-20 hours/day, is sometimes not feasible for mothers or caregivers. In addition, we also have the challenge of keeping preterm or LBW neonates warm during transportation. The scientists at icddr,b, Johns Hopkins University, and George Mason University developed the re-usable thermal jacket for keeping preterm or low-birth-weight neonate warm. We propose to build on previous work by systematically testing the safety of the 'thermal jacket' among preterm or low birthweight (LBW) neonates. Objective of this study is to conduct clinical safety trial of the thermal jacket to test whether the thermal jacket can retain euthermia of preterm or LBW neonates for 2 hours.
This study is looking at using a self-contained pH device that will assist in confirming placement of a nasogastric or orogastric tube placed in the stomach of hospitalized infants.
The goal of this interventional study is to investigate through musculoskeletal ultrasonography how the thickness and muscle trophism in infants aged 28 to 35 weeks undergoing infant massage compared with a group of infants with similar characteristics not subjected to treatment. The main questions it aims to answer are: - To assess by musculoskeletal ultrasound the impact of infant massage on muscle thickness muscle. Specifically, changes in muscle thickness and trophism of the quadriceps femoris. - Potential effects on spontaneous motility and stature-ponderal growth of infants. In addition, the discomfort and behavioral status of the infant before and after massage will be investigated infant. Patients included in the study will be randomized according to a random sequence with a 1:1 ratio into theexperimental group (GS) or the control group (GC). Patients in the GS will perform therapy with infant massage in addition to the usual rehabilitation therapies as specified by the program individual habilitative, to which patients in the control group will be subjected exclusively control. Infant massage will be performed three times a day (10 minutes per session) until they reach the 35th week of post-conceptional age (35+6) by the two departmental physical therapists (ADP and ADV). Ultrasound will be performed at the time of randomization (T0) and then 1 time per week until the 35th week by two operators (SN and VA); at the same time, the circumference of the thigh subjected to ultrasound examination. A 12Hz linear ultrasound probe will be used, applied perpendicular to the skin. The infant will be placed supine, with the thigh extended, in a neutral position; excessive compression will be avoided by applying a generous amount of gel. At the midpoint of the thigh, the thickness of the quadriceps muscle will be calculated by measuring the distance between the cortex of the femur and the most superficial muscle fascia. The average of at least 2 measurements will be then calculated. The Heckmatt scale will be used to assess the echogenicity of muscle and bone. In addition, at time T0 and at week 35 the following data will be collected: weeks gestational age, weight at birth and at the end of treatment, rectal temperature, blood gas parameters if present.
Children born preterm are recognized to be at higher risk of short and long term complications and a formal follow-up of infants and children born preterm is recommended by international and national scientific societies. However, in Italy as well as in Tuscany, such a follow up is not usually done, and data are not collected in a structured way. The goal of this observational study is to evaluate the association between a large number of early life exposures and health outcomes and access to care during childhood in infants born preterm. The main questions it aims to answer are: • what is the role of prenatal and perinatal factors in influencing health outcomes during childhood in preterm infants? • What is the role of prenatal and perinatal factors in influencing access to care during childhood? Participants will be asked to attend a follow-up visit for the purpose of collecting health data.
Human milk has several well-established benefits but does not adequately meet the increased nutritional demands of the growing preterm infant, necessitating additional nutrient supplementation in a process known as fortification. In U.S. neonatal intensive care units (NICUs), human milk is primarily supplemented using standardized fortification, in which a multicomponent fortifier is added to human milk to achieve assumed nutrient content based on standard milk reference values. However, this method does not account for the significant variability in human milk composition or in preterm infant metabolism, and up to half of all very premature infants experience poor growth and malnutrition using current nutritional practices. Poor postnatal growth has adverse implications for the developing preterm brain and long-term neurodevelopment. Recent advances allow for individualized methods of human milk fortification, including adjustable and targeted fortification. Adjustable fortification uses laboratory markers of protein metabolism (BUN level) to estimate an infant's protein requirements. In targeted fortification, a milk sample is analyzed to determine its specific macronutrient and energy content, with additional macronutrient supplementation provided as needed to achieve goal values. Emerging data suggest that both methods are safe and effective for improving growth, however information on their comparable efficacy and neurodevelopmental implications are lacking, particularly using advanced quantitative brain MRI (qMRI) techniques. Through this prospective, randomized-controlled trial, the investigators will compare the impact of individualized human milk fortification on somatic growth and neurodevelopment in preterm infants. Infants will be randomized to receive one of three nutritional interventions: standardized (control group), adjustable, or targeted human milk fortification. Infants will undergo their assigned nutritional intervention until term-equivalent age or discharge home, whichever is achieved first. Brain qMRI will be performed at term-corrected age, and neurodevelopmental follow-up will be performed through 5 years of age.