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Premature Birth clinical trials

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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.

NCT ID: NCT05514145 Completed - Space Maintenance Clinical Trials

The Effectiveness of Combined Design Nance/Transpalatal Arch Appliance in Maintaining Arch Dimensions After Premature Extraction of Primary Molars

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

This study will evaluate the effectiveness of N-TPA appliance compared to Nance SM in maintaining the arch dimensions after bilateral premature extraction of primary molars in children.

NCT ID: NCT05513768 Completed - Preterm Clinical Trials

PRETERM DELİVERY and MYOCINE BINDING PROTEIN C LEVELs

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

IT WAS AIMED TO EVALUATE IF MBPC CAN BE USED IN PREDICTION OF EARLY BIRTH. TAKING THE FIRST TRIMESTER FROM PREGNANCY WAS STORED UNTIL THE TIMING OF DELIVERY.THE PARTICIPANTS WERE SEPARATED INTO TWO GROUPS ACCORDING TO THE TIME OF BIRTH, EARLY AND TIMELY. SERUM MBPC LEVELS BETWEEN TWO GROUPS EVALUATED.

NCT ID: NCT05509621 Completed - Nursing Caries Clinical Trials

The Effect of Positions on Physiological Parameters of Preterm Neonates Receiving Mechanical Ventilation

Start date: September 1, 2022
Phase: N/A
Study type: Interventional

This study was planned as an experimental study with a randomized crossover design to determine the effect of supine, prone, right lateral, left lateral, and quarter prone positions used during daily routine care in the neonatal intensive care unit on physiological parameters (oxygen saturation, heart rate, respiratory rate) of preterm neonates receiving mechanical ventilation.

NCT ID: NCT05502510 Completed - Pregnancy Related Clinical Trials

Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application

Start date: September 23, 2019
Phase:
Study type: Observational

One in ten births will occur prior to 37 weeks of gestation leading to serious complications such as problems with lung, heart and brain function and an increased risk of infant mortality. Solutions exist to treat risk factors related to preterm birth but these solutions require timely identification of the risks which is often not possible within regular prenatal care. This study will evaluate MyHealthyPregnancy, an application that monitors for common risks associated with preterm birth and recommends solutions to the expectant mother and care team.

NCT ID: NCT05496400 Completed - Premature Clinical Trials

Anemia of Prematurity and Hemodynamics

Start date: July 1, 2021
Phase:
Study type: Observational

The aim of this work to study the hemodynamic changes accompanying anemia of prematurity in neonates with gestational age ≤32 weeks and the effect of its treatment on hemodynamics.

NCT ID: NCT05493540 Completed - Clinical trials for Patent Ductus Arteriosus After Premature Birth

Oral Ibuprofen Versus Placebo in Treatment of Patent Ductus Arteriosus (PDA)in Preterm Infants

Start date: April 15, 2021
Phase: Phase 2
Study type: Interventional

The management options of Patent Ductus Arteriosus are still controversial and differ between centers. Recently, conservative management has been gaining interest as the evidence of benefit from medical treatment in terms of mortality and morbidity is lacking. This study will compare oral ibuprofen (the standard treatment) with the conservative treatment, in terms of ductal closure and morbidity and mortality at discharge in preterm neonates less than 34 weeks.

NCT ID: NCT05492747 Completed - Premature Infants Clinical Trials

Kangaroo Care an EffectonTransitionTime From Gavage Feeding

KangarooCare
Start date: January 3, 2019
Phase: N/A
Study type: Interventional

Objectives: Kangaroo care is a safe and effective alternative method to conventional neonatal care for newborn babies. The aim of this study was to evaluate the effect of kangaroo care on the transition time to full oral feeding in preterm infants fed by gavage. Methods: This is a randomized controlled trial. This study was conducted in a level III neonatal intensive care unit of a university hospital in eastern Turkey 50 premature babies with a birth weight of ≥ 1000 g and a gestational age of 27-36 weeks, and their mothers were included in the study. The cases were randomly divided into two groups: kangaroo care, which would be applied up to five days a week, and standard care. Records of cases were kept regularly from their hospitalization until they reached full oral feeding.

NCT ID: NCT05465460 Completed - Preterm Birth Clinical Trials

Effect of Banana Blossom on Breast Milk Volume in Mothers of Preterm Newborns

Start date: July 13, 2022
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess the effect of banana blossom in increasing breast milk volume

NCT ID: NCT05462171 Completed - Clinical trials for Erectile Dysfunction

The Prevalence of Erectile Dysfunction (ED) and Premature Ejaculation (PE) in Poland

ED POLAND
Start date: July 1, 2022
Phase:
Study type: Observational

The first large population-based study to evaluate erectile dysfunction (ED) and premature ejaculation (PE) in Poland. The study objective is to assess the prevalence and bother of ED and PE in the representative group of male population of Poland.