Active clinical trials for "Premature Birth"

To investigate the effect of delayed cord clamping (DCC) on hematopoietic progenitor cells (HPCs), hematological parameters including haemoglobin concentration and hematocrit value in premature infants (34 weeks gestational age or less) with placental insufficiency.We hypothesized that preterm infants with placental insufficiency underwent DDC could have better hematologic parameters and hematopoietic progenitor cells compared to immediate cord clamping.

This study evaluates the safety and suitability of the two-stage feeding system in preterm infants.

The purpose of this study is to determine whether oral stimulation program are effective to improve oral feeding efficiency. The sample size estimated in 74 preterm, randomized classification of the subjects into to experimental and a control group.

Preterm birth is the leading contributor to mortality among children younger than 5 years. One effective and inexpensive intervention is providing skin-to-skin care (STSC) whereby the mother of a preterm baby provides skin-to-skin contact to the newborn for at least a few hours, ideally every day. This intervention can make breastfeeding easier and can improve the health and development of the baby. Unfortunately, despite the large health benefits, mothers in low-resource communities are often unable to practice STSC due to a range of institutional and economic barriers. STSC requires substantial time and financial commitments from mothers; they must travel from home each day to the hospital to engage in STSC and provide expressed breast milk. Low-income women with access only to limited federally provided unpaid family leave may have to choose between returning to work while their baby is in the NICU and being able to stay at home with their newborn after discharge from the NICU. Families of preterm infants also face direct financial costs of practicing STSC and breastfeeding (such as fees for parking and childcare for older children). This trial aims to examine the impact of providing additional support to low-income mothers of babies born preterm in 2 hospitals in Massachusetts to help them provide STSC. Half of the participants will be randomized to receive an additional financial support intervention while their infant is in the NICU. The study will examine how this intervention impacts mothers' health behavior while their child is in the NICU and up to three months after. Most of the current and past policy efforts to increase STSC have focused on the delivery of STSC at hospitals, focusing on supply-side related challenges such as the lack of trained and informed staff. However, interventions that focus exclusively on hospitals are unlikely to be sufficient for low-income women if there are significant opportunity costs or transportation costs to simply being present at the hospital. This study aims to provide more evidence to determine whether removing these financial barriers has the potential to mitigate the poor outcomes of preterm babies born to lower socioeconomic status households.

The proposed 2-year study has two specific aims: (1) to examine the effects of a "bundle" of supportive interventions on preterm infants' stress (salivary cortisol and dehydroepiandrosterone [DHEA] levels and physiological signals of infant distress), sleep, and physical activity in the NICU, and (2) to explore the relationships among preterm infants' salivary cortisol and DHEA levels, physiological signals of infant distress, sleep, and physical activity. This randomized controlled trial will adopt a longitudinal repeated-measures design to examine the effects of bundled supportive interventions on preterm infants' stress (salivary cortisol and DHEA levels [using ELISA kit] and physiological signals of infant distress [using bedside electrocardiographic monitors]), sleep and physical activity (using ankle actigraphy) during their NICU hospitalization. Preterm infants (N=120) meeting the study criteria will be randomly assigned to one of two conditions: (1) control condition: usual NICU care + positioning + gentle touch +routine kangaroo mother care (KMC) < 20 minutes; (2) experimental condition: the bundle of supportive interventions (usual NICU care +positioning + gentle touch + modulating infant states + facilitated tucking + non-nutritive sucking + oral sucrose+ routine KMC > 45 minutes. Outcome variables will include infants' biological responses to stress (salivary cortisol, salivary DHEA, and physiological signals of infant distress), sleep patterns, and physical activity.

Prematurity is the leading cause of neonatal morbidity causing more than 1 million deaths worldwide per year. In 2012, a randomized controlled trial (RCT) testing "pessary" (silicone ring placed around the cervix) versus "no pessary" in patients with a short cervix showed a 4-fold reduction in the rate of spontaneous prematurity <34 weeks of gestation and a reduction in perinatal morbidity and mortality. This result was not found in a subsequent RCT and another study on the subject had to be stopped in the face of slow recruitment. Currently, the obstetric scientific community believes that other RCTs are needed before using the pessary in the clinic as a therapeutic option to prevent prematurity in the presence of a short cervix. However, before starting a large RCT, it is important to test the feasibility of recruitment.

The purpose of this study is to compare neurodevelopment and activity in infants born preterm (25 to 34 1/7 weeks gestational age (GA)) receiving Standard Care (SC) or Family Nurture Intervention (FNI) in the neonatal intensive care unit (NICU). The investigators hypothesize that FNI will improve: i) neonatal electroencephalographic activity ii) maternal caregiving and wellbeing (psychological and physiological, and iii) infant behavior and neurodevelopment at 18 months corrected age (CA). The two-phase effectiveness study aims to: Phase 1 - Examine the existing Standard Care Approximately 35 infants and their mothers Phase 2 - Examine effectiveness by implementing FNI unit-wide so that every baby receives the intervention Approximately 35 infants and their mothers

The purpose of this research is to determine the effect of premature birth on later heart function and metabolism.

Progesterone can be given to women at risk for preterm birth, and is advocated by many guidelines as progesterone has been shown to markedly decrease preterm birth, death in newborns, and disability. However, not all eligible women are currently receiving this medication. Thus, there is an urgent need to improve prevention of preterm birth with progesterone. In response to the low number of women receiving this medication, the investigators have designed a potential method to increase progesterone use. This method involves the use of an "alert" programmed into electronic medical records, to prompt doctors to prescribe progesterone to women at risk of preterm birth. This study is a randomized controlled trial that will assess the feasibility of using this "alert", by randomly assigning 8 clinics to either use this alert, or to provide their usual prenatal care. The investigators will then study whether the alert improved prescription of progesterone, and examine neonatal outcomes such as preterm birth and birth weight. Care providers will be asked for their feedback and thoughts about the alert, through questionnaires and structured interviews. The investigators hypothesize that the electronic medical record alert will increase care provider recommendations and prescription of progesterone for women at risk of preterm birth. The investigators hope that this study will lay the groundwork for larger future studies aimed to strengthen health care quality and improve the health outcomes of women and their babies.

In this project three studies examined two possible explanations and one possible preventive intervention to early cessation of exclusively breastfeeding in premature infants. Study 1 The content of protein in the milk of mothers, who delivers prematurely, is about a third higher than in the milk from the mother who delivers on time. The nutritional composition changes over time and the content of protein decrease. Therefore the premature infant is at risk of protein deficiency. While the infant is feeding by tube this decreasing content of protein can made up by adding, while it is more difficult when the infant is exclusively breastfeeding. The hypothesis is that reduced protein content in breast milk is associated to a fewer number of days where the premature infant is exclusively breastfed. Study 2 The premature infant is characterized with immature muscle with a low tension and therefore, a low ability to eat its needs by breastfeeding the first period. The transfer of milk from mother to child is an interaction between the mothers and her milk ejection reflex that establish a positive pressure on the milk and the child that have to establish a vacuum. The hypothesis is that the premature infants suction power is too weak to establish sufficient intraoral vacuum to ensure milk transfer from the breast to the infant and it can be related to a fewer number of days where the infant is exclusively breastfed. Study 3 The premature infants low muscle tone and its immaturity also influence on the organization and the quality of movements, marked as neuro motor processes. These processes form the oral motor base supporting movement which involves the infant ability to establish vacuum. The hypothesis is that Oral Stimulation for a specific program in 5 minutes before the minimum 2 meals per. day for at least 14 days increases the preterm infant's ability to create intra oral vacuum and thus the power to transfer milk from the breast, thereby extending the number of days when the infant is exclusively breastfed. 200 infants are included consecutively, as a recurring cohort in all 3 studies. In Study 1 the mothers' milk is analyzed in order to the content of protein. In Study 2 the infant suction is assessed by vacuum measurement. In study 3 the families are randomized to an intervention or control group and parents off 100 infants are guided by occupational therapists in a program of oral stimulation of their child.