View clinical trials related to Infant, Very Low Birth Weight.
Filter by:This study was designed and conducted in an effort to establish a comparison group for the Ghana PrenaBelt Trial (NTC02379728). The Ghana PrenaBelt Trial examined the effect, on birth weight, of a belt-like device to help pregnant women to avoid sleeping on their back during sleep in the third trimester. This study will seek to establish the typical birth weight of babies born to a cohort of healthy pregnant Ghanian women who are similar in characteristics to the women in the Ghana PrenaBelt Trial but who have not been educated to avoid back sleep during pregnancy nor have received a device to prevent back sleep.
Recent studies showed the benefits of early initiation and advancement enteral feeds with daily increments in preterm infants on decreasing invasive infections and early achievement of full enteral feedings. But the data on enteral feeds of extremely low birthweight infants are limited. Preterm infants especially those <1250 gr birthweight are at increased risk of developing feeding intolerance and necrotizing enterocolitis (NEC) and so the initiation and the rate of increments of enteral feeds are usually uncertain issues for neonatologists.
In Canada, the leading cause of long-term disability in children is being born at very low birth weight (VLBW). To help improve outcomes, nutrition is a modifiable aspect of infant care. Mother's milk is the optimal way to feed VLBW infants; however, many need a supplement of donor milk or preterm formula as not enough mother's milk is available. As the ideal supplement for prolonged feeding and its long-term effects is currently unknown, this study is a prospective follow up of VLBW infants who in hospital were fed: donor milk or preterm formula and/or mother's milk. Areas of development to be assessed include: cognition, language, motor skills, brain structure/function, and body composition. A DNA biorepository will also be created.
This study evaluates the potential interest of a new multi-lumen infusion access device (Edelvaiss® Multiline NEO) in the prevention of catheter-related bacteremia when administering injectable drugs in premature infants. This device will be compared to the standard infusion set of each center.
Very low birth weight (VLBW) infants have more health and developmental problems than normal birth weight full-term infants. These problems are more common in males than female VLBW preterm infants. Male VLBW infants also experience less positive mother-infant interactions than females, especially when mothers are emotionally distressed. This is a significant problem because positive mother-infant interactions function as an important protective factor against the negative health and developmental outcomes associated with prematurity. The source of the vulnerability of male VLBW infants to health problems, suboptimal mother-infant interactions, and poor development goes beyond gender socialization differences and includes biological factors. Identification of infant and maternal biological markers/predictors of infant health and developmental outcomes could ultimately lead to interventions for VLBW preterm infants. The purpose of this study is to confirm that testosterone rather than cortisol is a more reliable marker/predictor of complications affecting infants' health outcomes, mother-infant interactions, and infant cognitive/motor/language developmental outcomes; and that male infants exhibit a higher sensitivity to testosterone levels than female infants. This longitudinal study will examine the associations of the steroid hormones, testosterone and cortisol, levels with infant health, mother-infant interactions, and infant cognitive/motor/language development ('infant development') in very low birthweight (VLBW, BW < 1,500 g) preterm (gestational age < 32 weeks gestation) infants after adjusting for maternal physical and mental health state, infant socioemotional and behavioral development, and characteristics of infants and mothers. Concurrent and repeated measurement of testosterone and cortisol levels both in infants and mothers will be conducted through infancy and early childhood (at birth, 40 weeks postmenstrual age, 12 and 24 months corrected age).
Neonatal hypoglycemia is associated with brain injury and impaired neurodevelopment outcomes in very low birth weight infants (VLBWI). Glycemic monitoring is usually performed by capillary or central line sampling but does not identify up to 81% of hypoglycemic episodes in preterm newborns. The investigators aim to assess if a continuous glucose monitor (CGM) can be used to maintain euglycemia (defined as a target value 72-144mg/dl) in VLBWI. It will be enrolled newborns ≤32 weeks gestational age and/or of birthweight ≤1500 g, within 48 hours of life, they will be randomized in two study arms, both them will wear Dexcom G4 Platinum CGM: 1) Unblinded group (UB): glucose daily intake will be modulated according to CGM (Dexcom G4 Platinum) during the first 7 days of life, alarms for hypos/hyper will be active; 2) Blinded group (B), glucose infusion rate will be modified according to 2-3 daily capillary glucose tests, alarms for hypos will be switched off. Pain at insertion will be evaluated with the validated Premature Infant Pain Profile (PIPP) scale. The estimated numerosity is 50 patients (25 for each arm).
A study to compare growth, development of the intestinal bacterial environment, and other short term outcomes in groups of babies fed primarily their own mother's milk compared to those who receive primarily donor human milk. The investigators hypothesize that infants who receive primarily their own mother's milk will have better growth, a more diverse intestinal bacterial environment, and possibly some improved short term outcomes such as better feeding tolerance and lower rates of infection.
Delayed cord clamping (DCC) from 30 to 60 seconds allows blood to continue to flow from the placenta through the umbilical cord to the infant, thus resulting in a placental transfusion. This transfusion may improve circulating volume at birth leading to a smoother postnatal transition and overall improved outcome for preterm infants. The average blood volume delivered with DCC up to 90 seconds in preterm infants has been estimated to be about 12 ml per kg with vaginal deliveries resulting in slightly higher transfusions compared to cesarean deliveries. Several several short-term benefits have been described including a reduction in the need for blood transfusions as well as a possible reduction in intraventricular hemorrhage and necrotizing enterocolitis. All mothers with threatened preterm delivery between 28 and 34 6/7 weeks will be approached for the study. Following consent, the infant will be randomly assigned to either a 30 or 60 second delay in cord clamping in the delivery room. If the infant is not breathing by 30 seconds, the cord will be clamped and the infant moved to a resuscitation area. The primary outcome is a 3 percent difference in the hematocrit at one hour (routinely obtained on all babies). With approximately 75 neonates in each group (30 and 60 second DCC), there is 80% power to detect a difference in the mean hematocrit of 3% using a two-sample t-test with a 0.05 two-sided significance level.
The purpose of this study is to explore the effects of Oropharyngeal administration of colostrum to very low birth weight infants on sIgA and lactoferrin, in order to explore the protect immune function of colostrum to very low birth weight infants, to improve the utilization of breast milk and reduce infection rates of very low birth weight infants.
Every day in Ghana, 47 babies are stillborn (SB) and 232 babies are born with low birth-weight (LBW) - many of whom will die in infancy or suffer lifelong consequences. Sleeping on the back during pregnancy has recently emerged in scientific literature as a potential risk factor for SB and LBW. In fact, one of the earliest studies to demonstrate this link was conducted in Ghana by investigators on this protocol. When a woman in mid-to-late-pregnancy lies on her back, her large uterus compresses one of the major veins that delivers blood back to her heart and may completely obstruct it. This may result in less blood being returned to her heart and less blood being pumped to her developing fetus. Such changes may negatively impact the growth of her fetus and, along with some other risk factors, may contribute to the death of her baby. The investigators have developed a device, 'PrenaBelt', to significantly reduce the amount of time a pregnant woman spends sleeping on her back. The PrenaBelt functions via a simple, safe, effective, and well-established modality called positional therapy. The purpose of this study is to determine the effect of the PrenaBelt on birth-weight and assess the feasibility of introducing it to Ghanaian third-trimester pregnant women in their home setting via an antenatal care clinic and local health-care staff. Data from this study will be used in effect size calculations for the design of a large-scale, epidemiological study targeted at reducing LBW and SB in Ghana and globally.