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Premature Birth clinical trials

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NCT ID: NCT05947877 Completed - Pain Management Clinical Trials

Non-Pharmacological Nursing Pain Management for Preterm Infants

Start date: January 2, 2023
Phase: N/A
Study type: Interventional

A randomized controlled trial will be conducted to examine the effect of non-pharmacological nursing pain management strategies in alleviating pain among preterm infants. The study includes a simple random sample of 105 preterm infants with CGA 32- < 37 weeks were randomly assigned into five groups: routine care (n = 21), breast milk (n = 21), oral sucrose (n = 21), KMC (n = 21), nesting position (n = 21). PIPP-R will be used to subjectively assess the pain intensity after heel stick, and salivary cortisol measures will be used to objectively assess the pain intensity in NICU at Children Welfare Teaching Hospital/ Medical City Complex in Baghdad City.

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: NCT05930522 Completed - Clinical trials for Psychomotor Development Impaired

Psychomotor Performance of Preterm Infants

Start date: October 1, 2018
Phase:
Study type: Observational

The first part involved 120 children in grades II and III of elementary schools. From this group, children were qualified for the second part of the study - 35 randomly selected children born on time (BoT) and 35 children born before 35 weeks of pregnancy (PB). EUROFIT tests, Vienna Tests and postural stability tests were carried out in both groups.

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: NCT05903872 Completed - Clinical trials for LACTATION IN MOTHERS WITH PREMATURE NEWBORNS

EFFECTS OF AROMATHERAPY MASSAGE ON LACTATION IN NON-BREASTFEEDING MOTHERS WITH PREMATURE NEWBORNS IN NEONATAL INTENSIVE CARE UNIT

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

This study was planned as a randomized controlled experimental study to investigate the effects of aromatherapy massage on lactation in non-breastfeeding mothers with premature newborns in neonatal intensive care unit. The population of the research, was consisted of all mothers who gave birth preterm in a city hospital in Istanbul between October 2022- April 2023. The sample of the study included a total of 36 mothers (18 in aromatherapy group, 18 in the massage group) who were randomly selected among the mothers who were over 18 years of age, had preterm (<37 weeks) cesarean section, had a single pregnancy, were on the first postpartum day, were asked to express their milk because of the baby's condition, and volunteered to participate in the study. The data of the study were collected with Participant Characteristics Form, Depression-Anxiety-Stress Scale (DAS-21), Lactation Onset Symptoms Evaluation Form, Milking Follow-Up Form and Visual Analog Scale (VAS) satisfaction evaluation form. The Participant Characteristics Form and the Depression Anxiety Stress Scale were administered to all mothers within the first 6-8 hours post-operatively, and manual milking training was given. For three days, twice a day (15 minutes each), aromatherapy massage was applied with a mixture of lavender, fennel and frankincense essential oils in almond oil as a carrier oil, while mothers in the massage group were only massaged with almond oil, which is only the carrier oil. Lactation symptoms were evaluated after the massage in both groups and the expressed milk amount was recorded after milking both breasts for at least 15 minutes. In addition, all mothers expressed their milk 8 times a day and recorded the total amount of milk in 24 hours. After the last application, their satisfaction with the application was evaluated with VAS. Descriptive statistical methods, chi-square, Mann Whitney and Friedman tests were used to evaluate the data.

NCT ID: NCT05901623 Completed - Clinical trials for Neurodevelopmental Abnormality

ASQ Scores of Transient Hypothyroxinemia of Prematurity

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

• Transient hypothyroxinemia of prematurity (THoP) is defined as free thyroxine (FT4) level is below the reference values despite normal TSH level in preterm infant. This study aims to evaluate the neurological development of infants with transient premature hypothyroxinemia (THoP).

NCT ID: NCT05892081 Completed - Diaper Rash Clinical Trials

Colloidal Oatmeal, Colloid Cream, Diaper Rash, Preterm Neonates and Neonatal Intensive Care Unit

Start date: August 20, 2021
Phase: Phase 4
Study type: Interventional

-This study aimed to investigate the effect of colloid oatmeal compared to colloid cream on diaper rash among preterm neonates in the NICU.

NCT ID: NCT05880433 Completed - Clinical trials for Retinopathy of Prematurity

The Effects of Mydriatic Eye Drops in Retinopathy of Prematurity Examinations

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

Retinopathy of prematurity (ROP) is a retinal disorder of preterm neonates and a potential cause of blindness. As early diagnosis and treatment preserve vision, very low birth weight infants must be screened for ROP. Mydriatic eye drop administration is essential to perform funduscopic evaluations. The most commonly used mydriatic drops for pupil dilatation are 0.5-1.0% tropicamide and/or 0.5-1.0% phenylephrine or 0.2-1.0% cyclopentolate. Phenylephrine, an alpha-1 sympathomimetic agonist, is readily absorbed from conjunctival mucosa and has a potent systemic vasopressor effect. Tropicamide causes cycloplegia by inhibition of ciliary muscle contraction and has a short acting para-sympatholytic effect. Systemic absorption of mydriatic eye drops has been associated with cardiovascular, respiratory and gastrointestinal adverse effects. Systemic side effects include apnea, desaturation, increased heart rate and blood pressure, delayed gastric emptying, and feeding intolerance. The data about the effects of mydriatics on cerebral blood flow and tissue oxygenation are sparse. Cerebral blood flow autoregulation depends in part on the adrenergic and cholinergic control of cerebral vasculature, but whether mydriatics have an effect on cerebral haemodynamics is unknown. Near-infrared spectroscopy and Doppler ultrasonography (US) are non-invasive methods commonly used for neuromonitorization in NICUs. The regional blood flow changes measured using Doppler US have been reported to be associated with cerebral oxygenation and indicate a high correlation with NIRS in newborns. The aim of this study was to evaluate the effects of mydriatic eye drops on cerebral oxygenation and blood flow in preterm infants by NIRS and Doppler US.

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: NCT05845684 Completed - Clinical trials for Neurodevelopmental Disorders

The Effect of the Physiotherapy Program Applied in the Neonatal Intensive Care Unit

Start date: December 31, 2021
Phase: N/A
Study type: Interventional

The aim of our study is to examine the effects of the physiotherapy program applied in the NICU on motor performance, behavior, transition time to full enteral feeding, and feeding performance in preterm infants.