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Feeding; Difficult, Newborn clinical trials

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NCT ID: NCT06336668 Not yet recruiting - Clinical trials for Feeding; Difficult, Newborn

Source of Human Milk Fortifier and Intestinal Oxygenation in Preterm Infants <30 Weeks Gestation

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Preterm infants require higher nutritional intakes during the neonatal phase than they do at any other stage of their development. Standard volumes of human milk alone do not offer sufficient nourishment to these infants. There are multiple options for fortifying human milk, which vary depending on whether the fortifier is derived from bovine sources (B-HMF) or human sources (H-HMF). Fortifying human milk has been proven to enhance growth in preterm infants without raising the risk of necrotizing enterocolitis (NEC), though it could potentially affect feeding tolerance. Changes in blood flow and oxygen levels in the intestines are commonly observed in infants experiencing feeding intolerance. Research indicates that feeding a mother's own milk (MOM) doesn't affect splanchnic (intestinal) oxygenation, whereas it decreases when feeding bovine-derived human milk fortifiers (B-HMF) or preterm formula, indicating greater oxygen requirements in the intestines of preterm infants fed these alternatives. The goal of this clinical trial is to compare the effect of H-HMF and B-HMF on splanchnic oxygenation in infants less than 30 weeks.

NCT ID: NCT05861531 Not yet recruiting - Clinical trials for Language Development

Learning to Talk, Learning to Eat: A Randomized Controlled Trial to Improve NICU Oral Feeding and Language Outcomes

Start date: June 1, 2023
Phase: N/A
Study type: Interventional

This is a randomized controlled trial to study an oromotor stimulation in combination with a reading curriculum in the NICU among preterm infants using oral muscle exercises, Language Environment Analysis (LENA) recordings, linguistic feedback, and a language curriculum to improve the neonatal inpatient oral feeding and language outcomes for preterm infants.

NCT ID: NCT05729828 Completed - Nurse's Role Clinical Trials

Psychometric Properties of the SMART Feeding Tool

Start date: May 5, 2021
Phase:
Study type: Observational

This observational study aims to evaluate the psychometric properties of a new infant feeding tool called "SMART Tool" in the neonatal intensive care unit. The main questions it aims to answer are: 1. To design a feeding tool to assess oral motor and neurobehavioral skills in neonates 2. To establish psychometrics of the new tool by doing reliability and validity tests.

NCT ID: NCT05687708 Completed - Clinical trials for Hypoxic-Ischemic Encephalopathy

Effect of Non-nutritive Sucking on Transition to Oral Feeding in Infants With Asphyxia

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

The transition period to full oral feeding in infants with perinatal asphyxia is important in predicting long-term outcomes. The transition to independent oral feeding is accepted as a discharge criterion by the American Academy of Pediatrics, and the long transition from tube feeding to oral feeding prolongs the discharge process. Prolonged transition to oral feeding increases maternal stress as it delays gastrointestinal problems, mother-infant interaction and attachment, as well as increasing health expenditures. Due to long-term feeding tube use; Infection, leakage, delay in wound healing, trauma caused by repeated placement, as well as oral reluctance are observed. In asphyxia infants, in whom oral-motor dysfunction is common, the transition to oral feeding takes a long time and tube feeding support is required. The effect of hypothermia, which is a general therapeutic intervention that reduces the risk of mortality and morbidity in infants with asphyxia, on oral feeding has been previously studied and shown to have a positive effect. They also found that MR imaging in infants with asphyxia and the need for gastrostomy and tube feeding in those with brainstem involvement were associated. Various interventions that affect the transition to oral nutrition positively and shorten the discharge time are included in the literature. Stimulation of non-nutritive sucking (NNS) is the most frequently preferred method among these interventions. It has been shown in studies that there are no short-term negative effects of NNS stimulation with the help of a pacifier or gloved finger, and some clinical benefits such as better bottle feeding performance, acceleration of discharge and transition to oral feeding. The effect of the NNS stimulation method, which has been shown to be effective in preterm infants with large-scale randomized controlled studies, is not known exactly. The aim of this study is to examine the effect of NNS stimulation applied to oral feeding, feeding skills, weight gain and discharge in asphyxia infants receiving hypothermia treatment.

NCT ID: NCT05525091 Recruiting - Feeding Patterns Clinical Trials

Neoneur Feeding System Functionality in the Clinic

NN200
Start date: July 14, 2022
Phase: N/A
Study type: Interventional

Prospective data collection using the Neoneur Feeding System to demonstrate device functionality, correlation to historic data, and prepare for a more extensive phase II SBIR trial

NCT ID: NCT05310851 Recruiting - Preterm Clinical Trials

The Effect Of Oral Motor Stimulation And Nonnutritive Sucking To The Time Of Transition To Oral Nutrition In Preterm

Start date: April 10, 2022
Phase: N/A
Study type: Interventional

Oral feeding difficulty is one of the problems that preterm infants frequently experience due to poorly developed oral musculature. Sucking and swallowing are present in early fetal life, but sucking-swallowing and swallowing-respiratory coordination are respectively occurs after the 32 and 33-34 gestational week (GA). For this reason, although there are sucking movements in preterm babies with gestational weeks of 31 and below, oral feeding is difficult because adequate coordination cannot be achieved during sucking-swallowing and breathing. Until these structures develop, preterm babies are fed by gavage (nasogastric/orogastric route) in intensive care units. Gavage feeding causes many negativities such as preventing the advantages of oral nutrition and creating an entry route for infectious agents, and the discharge is also delayed. Thus, infants are exposed to adverse intensive care conditions for a longer period of time. For this reason, it is important to ensure the transition to full oral nutrition as soon as possible. There are various methods that facilitate the transition of infants to oral feeding. Pacifier and oral stimulation applications are some of them. Oral stimulation was first applied by Fucile et al (2002). It is a method consisting of a total of 15 minutes, in which therapeutic touches are made for 12 minutes before feeding, and in the last few minutes, non-nutritive sucking is applied. Later, Lessen thought that this intervention was longer than the fragile preterm babies with a small oral cavity and shortened the duration of the intervention and reformatted it. This intervention, called "Premature Infant Oral Motor Intervention (PIOMI)" (Preterm Infant Oral Motor Intervention), is a 5-minute application consisting of 3 minutes of massage and 2 minutes of non-nutritive sucking. In the literature review, a study comparing oral motor stimulation and pacifier method was reached. However, in this study, unlike our study, a pacifier was applied to one of the groups, a 12-minute stimulation to the second, and a 12-minute stimulation and pacifier to the third. In our study, there are 3 groups. one of the groups a pacifier will be applied to one group and a 5-minute oral stimulation program will be applied to the other group. The third group is the control group. The aim of the study is to evaluate the effect of pacifier and oral stimulation applied to preterm infants on the transition time to oral feeding.

NCT ID: NCT05307497 Completed - Clinical trials for Feeding; Difficult, Newborn

An Exploration of Antenatal Hand Expression.

Start date: February 7, 2019
Phase:
Study type: Observational

The study is an exploration of mother's experiences of antenatal hand expression of colostrum, and the effects upon breastfeeding continuation and maternal emotional health

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: NCT04812249 Not yet recruiting - Pre-Term Clinical Trials

Effect of Co-morbidities on the Development of Oral Feeding Ability in Pre-term Infants

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

The aim of this study is to investigate the effect of co-morbidities on the timing of the achievement of full oral feeding in a cohort of pre-term infants and to evaluate their mode of feeding and feeding status at the time of hospital discharge.

NCT ID: NCT04599010 Not yet recruiting - Body Composition Clinical Trials

Role of Body Composition in Large for Gestational Age Infants (LGA) With Oral Feeding Difficulty

Start date: May 15, 2024
Phase: N/A
Study type: Interventional

Large for Gestational Age (LGA) infants have excess fat-mass (FM) proportion secondary to prolonged in utero exposure to an energy-rich environment. Our preliminary data suggest that excess FM proportion can be associated with oral feeding delay and a potentially modifiable therapeutic target to improve oral feeding outcomes. The objective of this study is to determine the impact of a short-term Fat-free mass (FFM)-indexed feeding on the oral intake volumes in LGA infants with oral feeding difficulties.