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Preterm Birth clinical trials

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NCT ID: NCT06216379 Completed - Preterm Birth Clinical Trials

Sensory Processing Associated With Motor Skills

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

In the study, sensory processing skills of 1-year-old preterm and term children will be evaluated. The relationship between sensory processing skills and gross and fine motor development will be investigated.

NCT ID: NCT06198478 Completed - Preterm Birth Clinical Trials

Tandem: Skin-to-skin Transfer From the Delivery Room to the Neonatal Unit

Tandem
Start date: March 3, 2017
Phase:
Study type: Observational

Immediate skin-to-skin contact (SSC) is already standard care for healthy term newborns, but its use for term or preterm newborns requiring admission to neonatal unit (NICU) with or without respiratory support is challenging. This study aimed to assess the safety and feasibility of SSC during the transfer of newborn infants, using a new purpose-built mobile shuttle care-station, called "Tandem". A monocentric prospective observational study was conducted at the tertiary referral center of the Université libre de Bruxelles in Brussels, Belgium Infants born with a birth weight above 1500g were eligible. Following initial stabilization, infants were placed in SSC with one of their parents and transferred to the NICU using the Tandem.

NCT ID: NCT06101186 Completed - Preterm Birth Clinical Trials

The Effect of Nursing Counseling Perceived Stress, Coping and Birth Outcomes Among Pregnant Women

Start date: March 30, 2020
Phase: N/A
Study type: Interventional

Aim: The aim of this study is to determine the effect of the Pregnant Nursing Education and Counseling Program (HEGDAP), which is structured on the Neuman Systems Model, on the perception of stress, coping with stress and birth outcomes in pregnant women with preterm labor risk. Method: This study was conducted with 60 pregnant women at risk of preterm labor, including 30 experimental and 30 control, non-randomized double-blind pregnant women using pretest, interim follow-up and posttest. Data were collected using a personal information form, Perceived Stress in Risky Pregnancies Questionnaire, Ways of Coping with Stress Scale and Birth Outcomes Evaluation Form. Nursing counseling based on Neuman's System Model was applied to the intervention group. Data were evaluated using analysis methods such as t-test, chi-square, etc.

NCT ID: NCT05978674 Completed - Preterm Birth Clinical Trials

The Effect of Rocking Bed on Preterm Newborns

Start date: March 15, 2021
Phase: N/A
Study type: Interventional

The study was planned to determine the effect of rocking bed applied to preterm newborns on comfort, physiological parameters and cerebral oxygenase level (rSO2).

NCT ID: NCT05944094 Completed - Preterm Birth Clinical Trials

Preterm Labor Prevention Using Vaginal Antiseptics Prior to 16 Weeks of Gestation

PLUVA
Start date: June 1, 2021
Phase:
Study type: Observational [Patient Registry]

The aim of this prospective observational study was to evaluate the efficacy of a universal strategy of primary prevention of preterm birth using intravaginal chlorhexidine (CLX) applied before 16 weeks. The main question is whether universal treatment with vaginal CLX before 16 weeks would reduce the incidence of preterm birth, especially before 34 weeks. Participants were recruited at the routine first trimester consultation. All patients underwent an initial ultrasound examination between 6+0 and 15+6 weeks gestation, including assessment of embryo/fetus vitality. Antiseptic treatment aimed at reducing possible bacterial overgrowth consisted of 10 days (1 box) of CLX vaginal ovules (CLX digluconate 0.2%) always starting between 9+0 and 16+0 weeks. As this product is widely marketed and frequently indicated in gynaecology, we did not deprive the non-treated group of treatment because we wanted to assess whether it could have an effect on reducing preterm delivery. The pregnant women were then followed up until the end of pregnancy and compared with a cohort of patients who had not received any treatment. All data related to delivery were collected, as well as any events related to preterm delivery, such as onset of contractions, cervical shortening and premature rupture of membranes, regardless of final gestational age at delivery.

NCT ID: NCT05930327 Completed - Preterm Birth Clinical Trials

COIN: A Pilot Study of Cash Transfers to Improve Outcomes in Low-Income Preterm Neonates and Their Families

Start date: July 26, 2023
Phase: N/A
Study type: Interventional

The investigators are conducting a pilot randomized controlled trial of unconditional cash transfers among Medicaid-eligible birthing parents of preterm infants in a single neonatal intensive care unit (NICU) in Pennsylvania. The investigators will measure the feasibility and acceptability of the intervention, birthing parents' lived experiences of having a preterm infant and the impacts of cash transfers, and conduct a preliminary assessment of efficacy on birthing parent psychological stress and ability to invest in their infant's care.

NCT ID: NCT05852899 Completed - Preterm Birth Clinical Trials

Evaluation of Preoperative Risk Factors in Children

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

1. The investigators aimed to make a more advanced risk assessment in predicting preoperative intensive care unit admission in pediatric patients. 2. The investigators aimed to better define the pediatric patient population and identify preoperative risk factors in detail in order to reduce perioperative complications.

NCT ID: NCT05729698 Completed - Preterm Birth Clinical Trials

Efficacy of A Novel in Prevention of Neonatal Hypothermia

Start date: December 1, 2020
Phase: N/A
Study type: Interventional

The research was carried out to determine the effect of baby warmer swaddle, which has a heating system used after the birth of preterm babies, on the development of hypothermia. Design: Randomized controlled clinical trial Setting: The research was carried out in the NICU of a training and research hospital in Istanbul. Method: A total of 65 babies between 32-37 weeks of gestation were included in the study. In accordance with the routine procedure of the clinic, preterm babies wrapped in polyethylene bags after birth formed the control group (n=33), while babies wrapped in polyethylene bags and placed in a swaddle with a heating system formed the experimental group (n=32).

NCT ID: NCT05693285 Completed - Clinical trials for Cardiovascular Diseases

Preterm Birth and Biomarkers for Cardiovascular Disease

BIO-PRETERM
Start date: November 14, 2022
Phase:
Study type: Observational

Preterm birth is associated with maternal increased risk of cardiovascular disease later in life. In an observational case- control study, investigators want to evaluate whether women with preterm birth have increased levels of biomarkers for cardiovascular disease, to reveal potential pathophysiological mechanisms in common.

NCT ID: NCT05515211 Completed - Preterm Birth Clinical Trials

Diagnostic Accuracy of Foot Length in Predicting Preterm and Low Birth Weight Using Ultrasound Dating as The Gold Standard in a Rural District of Pakistan

Start date: November 7, 2022
Phase:
Study type: Observational

Background: The burden of preterm and low birth weight babies (LBW) is high in low- and middle-income countries (LMICs). Therefore, assessment of gestational age (GA) and birth weight is important. The GA is assessed using a reliable last menstrual period (LMP), measuring fundal height, using ultrasound for dating, or postnatally using Ballard, Dubowitz, or Eregie scores. However, each method has some limitations. Pregnant women in LMIC are not able to recall LMP and are also unreliable when menstrual cycles are irregular, fundal height is often imprecise and subject to variation due to observer bias, uterine pathologies, abdominal obesity, amniotic fluid volume, fetal position, and ultrasound in a rural setting is often unreliable because lack of trained sonologist, power failures, and maintenance of ultrasound machine. Post-natal GA scoring is also lengthy, subjective, and time-consuming. Similarly, determining birth weight has many challenges. In Thatta, weighing scales are only available in health facilities, therefore, birth weight is available for babies born in the health facilities. Furthermore, even where weighing scales are available, the calibration and maintenance are not without challenges, especially in the extremely hot climate. In the majority of studies, foot length has been validated for determining GA and birth weight, with LMP serving as the gold standard, which has limitations in our population. In a meta-analysis on the diagnostic accuracy of foot length to identify preterm and LBW, researchers emphasized the need for studies using high-quality ultrasound as a reference standard for early dating. Hence, there is a need to develop a simple and effective method of GA and birth weight that healthcare providers of all levels including mid-level healthcare workers in remote areas can use with reasonable accuracy. Objectives of the study The primary objectives of the study are to determine the diagnostic accuracy of foot length in predicting GA and low birth weight using ultrasound conducted between 6-20 weeks for the predicted estimated date of delivery (EDD) as the gold standard. Secondary objectives of the study are, 1) to develop the regression equations that predict gestational age and low birth weight using foot length, 2) to assess the use of foot length measurement as a screening tool to identify LBW or preterm infants in a community-based setting, and 3) to develop percentile charts of foot length for gestational age and low birth weight Methods: This test validation study will be conducted in Global Network's Maternal and Newborn Health Registry catchment area. All live birth singleton babies who have a first-trimester ultrasound for gestational age and birth weight within 48 hours of birth will be included in this study. Stillbirths, multiple pregnancies, gross congenital malformations such as neural tube defects, omphalocele, etc., club foot, and babies with chromosomal abnormalities such as Down syndrome that make measuring foot length difficult, will be excluded from the study. Gestational age will be assessed using ultrasound between 6-20 weeks of gestation by a trained sonographer working in the registry. Neonatal assessment having neuromuscular, and physical signs will be conducted by the research assistants (RA). RA will be taking anthropometric measurements such as birth weight using calibrated weighing scales, foot length, mid-upper arm circumference, and fronto-occipital circumference. The data will be entered in Epicollect data five. Sensitivity, specificity, positive & negative predictive value, likelihood ratios, and diagnostic accuracy will be done using different cut-offs of foot length against ultrasound estimated gestational age and birth weight. Receivers operating characteristics (ROC) curves will be generated to identify the optimal cut-off point for foot length taken within 24 hours of birth for identification of prematurity and LBW (based on first-trimester ultrasound) with ≥80% sensitivity. Linear regression will be done for estimating predictive values of foot length by GA. Pentile charts for foot length (FL) against GA will be derived. Bland Altman's analyses will identify and quantify any biases inherent to the tool. Public health implications: If these equations predict gestational age and birth weight with accuracy, an android-based application can be developed for health care providers (HCP) who simply measure foot length and enter it into the application to identify preterm &/or low birth weight along with referred guidelines for early treatment. This is one step closer to Every Newborn Action Plan's goal of lowering neonatal mortality to 12/1000 LB by 2030.