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Preterm Birth clinical trials

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NCT ID: NCT03023267 Completed - PreTerm Birth Clinical Trials

The Contribution of Parent-infant Interaction While Singing During Kangaroo Care, on Preterm-infants' Autonomic Stability and Parental Anxiety Reduction

Start date: August 28, 2017
Phase: N/A
Study type: Interventional

The current study will investigate the combination of the two modalities in a mixed-methods design, in order to provide comprehensive knowledge regarding the effects of family-centered MT during KC, on premature-infants' autonomic nervous system stability (measured by parasympathetic tone, physiological vital signs and behavioral states); Parents' anxiety levels; And parents' unique experiences of the intervention. Additionally, the study will analyze separately mothers and fathers to elucidate similar and different effects

NCT ID: NCT03013660 Completed - PreTerm Birth Clinical Trials

Supporting Mothers of Preterm Infants

Start date: January 2017
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03007186 Completed - PreTerm Birth Clinical Trials

Glucose Monitoring During Threatening Preterm Birth in Patients With and Without Gestational Diabetes Mellitus

Start date: October 2016
Phase:
Study type: Observational

This study aims to show whether the hyperglycaemic phases following a treatment with glucocorticoids, as well as blood measurements correlated to high blood glucose levels and insulin resistance, vary significantly between patients with and without gestational diabetes mellitus.

NCT ID: NCT03005496 Completed - PreTerm Birth Clinical Trials

The Effect of Zinc, β-carotene, and Vitamin D3 in Preterm Delivery Through Placental MyD88, TRIF, NFkB, and IL-1β

Start date: January 2017
Phase: Phase 4
Study type: Interventional

This study is a controlled trial which compares the effect of zinc, beta-carotene, and Vitamin D3 supplementation in pregnant women which has preterm birth. The measured outcome is zinc, vitamin A, and 25(OH)D level in serum and placenta, MyD88, TRIF, NFκB, and IL-1β levels in placenta.

NCT ID: NCT02999061 Completed - PreTerm Birth Clinical Trials

Prevalence of Dental Caries in Preterm Birth Children Aged 2-5 Years in Primary Dentition

Start date: December 2016
Phase: N/A
Study type: Observational

The purpose of the study is to determine the prevalence of dental caries in preterm birth children aged 2-5 years in primary dentition.

NCT ID: NCT02993744 Completed - Preterm Birth Clinical Trials

Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone

Start date: September 2016
Phase: N/A
Study type: Observational

It is the aim of this study to detect the effect of Betamethasone on the maternal inflammatory parameters C-reactive protein (CRP) and leukocytes of a pregnant woman under threat of preterm delivery, for example because of a cervical infection.

NCT ID: NCT02986802 Completed - PreTerm Birth Clinical Trials

Comparative Effectiveness of Treatment Options for Genital Herpes Infection to Reduce Adverse Pregnancy Outcomes

PCORIHSV
Start date: March 14, 2017
Phase:
Study type: Observational

Preterm delivery (PTD), together with low birthweight (LBW), is the leading cause of infant death and illness, affecting 500,000 births with annual medical costs of more than $26 billion in the U.S. each year. Identifying changeable risk factors to reduce PTD is considered a top research priority. Recent research has shown genital herpes infection (HSV) is associated with increased risks of PTD and LBW. More importantly, treating this infection, including infection with no symptoms, using readily available antiviral medications can be effective in removing the risk due to HSV. Thus, early identification and treatment of HSV in pregnant women could be an effective way to prevent PTD and LBW. Currently, many pregnant women with HSV infection, especially those with no symptoms, choose not to treat due to (a) a lack of demonstrated benefit of treatment and (b) general hesitance to use medications during pregnancy due to safety concerns for the fetus. Thus, emerging evidence of an increased risk of PTD/LBW associated with HSV infection, if untreated, and treatment effectiveness by anti-herpes medications has significantly changed current treatment paradigms among pregnant women. This evidence also provides new hope that effectively treating HSV infection among pregnant women, especially before the 3rd trimester, could lead to a new method to reduce PTD and LBW and reduce racial/ethnic disparities in these risks due to high rates of the infection in minority groups. To further examine the effectiveness of treating HSV in pregnant women to reduce adverse pregnancy outcomes, the investigators propose to conduct a prospective cohort study with a two-stage design combining the large pregnant women population (N=90,000) in Stage I identified through Kaiser Permanente Northern California (KPNC) electronic medical records (EMRs), with a Stage II sample to collect detailed information on additional factors that might muddle our understanding of this issue. This study will address the following: (1) Does treating HSV infection in pregnant women reduce the risk of PTD or LBW? (2) Does timing of the treatment during pregnancy influence treatment effectiveness? (3) Do other factors influence treatment effectiveness? and (4) Does HSV infection in pregnancy, if untreated, increase the risk of PTD and LBW, compared to no infection? Answers to these questions will be valuable to pregnant women and clinicians, and directly address their concerns when making treatment decisions

NCT ID: NCT02970994 Completed - PreTerm Birth Clinical Trials

Linear Growth and Neurobehavioural Outcome in PT Neonates (<34 Wks) at 37 and 40 Wks of CGA

Start date: January 2015
Phase: N/A
Study type: Observational

This study will evaluate the association of linear growth on neurobehavioural outcome in preterm neonates at 37 and 40 weeks of (CGA) corrected gestational age.

NCT ID: NCT02970552 Completed - PreTerm Birth Clinical Trials

Feasibility of Vaginal Progesterone to Reduce HIV-Associated Preterm Birth

VP
Start date: July 1, 2017
Phase: Phase 4
Study type: Interventional

More than 1.5 million HIV-infected women become pregnant each year. Approximately half have access to antiretroviral therapy (ART), but all are at increased risk of preterm birth (PTB). Vaginal progesterone (VP) is a promising and cost-effective intervention to prevent PTB that should be studied in this high-risk population. This pilot study will provide critical insight into the feasibility of a phase III trial by determining whether women are willing to participate, to adhere to study drug, and to complete follow-up.

NCT ID: NCT02855814 Completed - Preterm Birth Clinical Trials

Body Composition Reference Data for Preterm Infants

Start date: June 2010
Phase:
Study type: Observational

The American Academy of Pediatrics has recommended that growth in size (weight, length, and head circumference) and in body composition (fat and lean mass) in preterm infants should adhere as close as possible to the growth and body composition of a healthy infant in utero at the same gestational age. However, there are no body composition reference curves available at this time for the preterm infant population. The purpose of this study is to collect cross-sectional body composition data using air displacement plethysmography (PEA POD Infant Body Composition System, Life Measurement, Inc) on approximately 240 preterm infants within 3 days of birth, for the purpose of generating means, standard deviations, and percentile values for total body fat mass, total fat free mass, and percent body fat for infants born at 30-36 weeks gestation. Relatively healthy infants without evidence of growth retardation will be selected for form the reference sample. The goal is to generate a set of common reference curves to be used in clinical centers against which to compare body composition status for individual infants.