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Premature Birth clinical trials

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NCT ID: NCT04945967 Completed - Premature Clinical Trials

A New Intervention Method to Enhance Oral Feeding Ability in Premature Infants: A Randomized Controlled Trial

Start date: August 13, 2021
Phase: N/A
Study type: Interventional

Indonesia is the fifth country with the highest number of premature infants in the world. Research has shown that as many as 40% to 70% of premature infants exhibit both immature and atypical feeding skills and those requiring respiratory support and those experiencing delays in beginning oral feeding are most often affected. Majority of premature infants have poorly developed suck and swallow mechanisms. The neurological immaturity, abnormal muscle tone, depressed oral reflexes, and difficulty in regulating state, can decrease the quality of infant's oral motor skills and the quantity of intake. For these reasons many high-risk infants are unable to tolerate oral feeding from birth and have difficulty making the transition from tube feedings to functional oral feeding. This transition to full oral feeding is an important competency for the infant to attain prior to discharge home. Delays in discharge are often secondary to feeding difficulties, leading to increased medical costs. Currently a number of treatment strategies exist to facilitate oral feeding in premature infants. These include environmental/physical modifications such as eliminating external stimuli during feedings, using therapeutic nipples to manipulate flow rate, positioning and swaddling to support the motor system and improve flexion, and oral motor intervention including Non-nutritive sucking (NNS) stimulation and oral/perioral stimulation. There are known various methods of oral and perioral stimulations. Recent study claimed that oral stimulations combined with non-nutritive sucking stimulation in premature infants for at least 10 days period could facilitate oral feeding ability. The therapy of new method intervention that will be studied in this research was a combination of physiological flexion in therapeutic positioning with specific swaddling techniques, oral stimulation, stimulation of synergistic movements, and stimulation of non-nutritive sucking using a special designed pacifier according to the size of premature infant's oral cavity. The objective of this study is to determine the time span required for premature infant to achieve safe and efficient oral feeding after new method intervention. Therefore, this new method expectedly can be used as an intervention to improve oral feeding ability in premature infant.

NCT ID: NCT04945369 Recruiting - Preterm Children Clinical Trials

Follow-up During the Peripubertal Period of Preterm Children Included in the Protocol Entitled "EPIPOD".

INFANTPOD
Start date: February 2, 2022
Phase: N/A
Study type: Interventional

Prematurity is associated with an increased risk of developing cardiovascular and metabolic disturbances in adulthood. It has been demonstrated that the body composition of children born prematurely is different from that of children born under term with a deficit in fat free mass. It can thus be wondered if this excessive adiposity does or does not predict the risk of insulin resistance in adulthood. Children born prematurely, with a body composition measurement performed at discharge from neonatal hospitalization as part of the EPIPOD protocol, and now aged between 8 and 14 years, will be included in the INFANTPOD protocol. Analysis of body composition, insulin resistance, renal function, pulse wave velocity, eating behaviour and of physical activity will be performed.

NCT ID: NCT04944108 Completed - Preterm Birth Clinical Trials

LISA vs INSURE in Extremely Low Birth Weight Infants. A Manikin Study

Start date: December 16, 2021
Phase: N/A
Study type: Interventional

This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA vs. INSURE in a manikin simulating an extremely low birth weight infant. Participants will be level III NICU consultants and residents. Randomization will be performed using a computer-generated random assignment list. The primary outcome measure will be the total time of device positioning. The secondary outcomes will be the success of the first and the participant's satisfaction.

NCT ID: NCT04943354 Completed - Clinical trials for Cardiovascular Diseases

Associations of Combinations of Single-nucleotide Polymorphisms in Women With Premature Ovarian Failure

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

Research objective. - To study the associations between combinations of single nucleotide polymorphisms and behavioural risk factors with non-communicable diseases and adverse outcomes in women with premature ovarian failure. Research objectives: - To study the associations between combinations of single-nucleotide polymorphisms and behavioural risk factors with heart rate disorders and adverse outcomes in women with premature ovarian failure - Examine the associations between combinations of single nucleotide polymorphisms and behavioural risk factors with stable STIs in women with premature ovarian failure. - Examine the associations between combinations of single nucleotide polymorphisms and behavioural risk factors with thrombomolia in women with premature ovarian failure - Study the associations between combinations of single nucleotide polymorphisms and behavioural risk factors and adverse cardiovascular outcomes in women with premature ovarian failure.

NCT ID: NCT04939571 Recruiting - Clinical trials for Retinopathy of Prematurity

European Disease Registry on Retinopathy of Prematurity (ROP)

EU-ROP
Start date: August 6, 2021
Phase:
Study type: Observational [Patient Registry]

The EU-ROP registry is a European wide multicenter non-interventional observational registry study intended to run open-ended in as many countries as possible including infants treated for retinopathy of prematurity irrespective of the used treatment modality. The registry is strictly observational; only clinical routine data is collected, no study-specific examinations or interventions are to be performed. The aim of the EU-ROP registry is to collect information on as many patients as possible treated for ROP in Europe. Both the number of study centers as well as the number of patients to be included into the registry are not limited. The primary objective is to describe the typical clinical features of infants with severe ROP, variations in phenotype, and the clinical progression of the disease over time (natural history) in different European countries as well as to study treatment patterns, follow-up patterns, as well as long-term outcomes.

NCT ID: NCT04933812 Completed - Preterm Birth Clinical Trials

EngagINg the COmmunity to Reduce Preterm Birth Via Adherence To an Individualized Prematurity Prevention Plan

Start date: June 21, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if INCORPorATe IP3 is feasible prior to a larger trial focused on determining efficacy. Feasibility will be measured using the RE-AIM framework4: Reach or Participation (Primary Outcome): (a) percent of eligible participants who are successfully recruited and attend at least one group session; Effectiveness: retention rate in the intervention; Implementation: fidelity to the intervention protocol; Maintenance: intervention sustainability based on continued engagement from the participants.

NCT ID: NCT04932044 Recruiting - Quality of Life Clinical Trials

Sleep Program on Preterm Infants' Sleep, and Caregiver's Sleep, Stress, Quality of Life, and Attachment

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

This research plan to construct an "Early Sleep Facilitation Program"and to explore the effects of the "early sleep Facilitation program" on the sleep and health of preterm infants and the sleep, stress, quality of life and attachment of the caregiver for a Long-term follow-up research. The proposed study has six specific aims: 1. Explore the effect of "Early Sleep Facilitation Program" on the sleep of preterm infants during hospitalization and after returning home. 2. Explore the effect of "Early Sleep Facilitation Program" on the health of preterm infants during hospitalization and after returning home. 3. Explore the effect of "Early Sleep Facilitation Program" on the sleep of the caregiver after preterm infants during hospitalization and after returning home. 4. Explore the effect of the "Early Sleep Facilitation Program" on the stress of the caregivers of preterm infants during hospitalization and after returning home. 5. Explore the effect of "Early Sleep Facilitation Program" on the quality of life of the caregivers of preterm infants during hospitalization and after returning home. 6. Explore the effect of "Early Sleep Facilitation Program" on the attachment of the caregivers of preterm infants during hospitalization and after returning home.

NCT ID: NCT04922671 Completed - Preterm Birth Clinical Trials

Development of a Screening Tool By Utilising Cervical Length Measurement In Relation To Body Mass Index (BMI) For Early Identification And Intervention Of Preterm Birth

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

This is a prospective study where pregnant women between 16-24 weeks gestation attending the Antenatal Clinic, Fetomaternal clinic or Obstetrics & Gynaecology Admission Centre (OGAC) at Hospital Serdang or Hospital Pengajar UPM will be recruited. BMI will be taken both during booking of pregnancy and at recruitment. Cervical length will be measured via transvaginal scan at recruitment time. We aim to assess the association between body mass index, cervical length and risk of preterm birth.

NCT ID: NCT04922398 Not yet recruiting - Clinical trials for Premature Ovarian Failure

Ovarian Injection of PRP (Platelet -Rich Plasma) Vs Normal Saline in Premature Ovarian Insufficiency

Start date: June 20, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

60 cases with premature ovarian insufficiency will be randomized to either receive PRP or saline injection in their ovaries. Then follow up by hormonal & ultrasound & clinically to monitor any changes

NCT ID: NCT04922242 Recruiting - Premature Birth Clinical Trials

Welch Emotional Connection Screen (WECS) in the NICU

Start date: April 17, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to assess knowledge about emotional connection, attitude about relational health, and efficacy of Welch Emotional Connection Screen (WECS) training in the NICU. The investigators seek to discern if through this didactic training, frontline NICU clinicians can be taught to reliably use the WECS to rate parent-child relational health. Additionally, the investigators seek to learn if there is construct and theoretical validity of the hospitalized infant preterm WECS by correlating WECS scores to physiological, behavioral and mental health markers for parent and infant.