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Improving Gastrointestinal Function In High-Risk Newborns By Stimulation Of The Enteric Nervous System (NeoHemoHapt)

Primary Purpose

Feeding and Eating Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HAPTOS (Handling Adapted to Postnatal age with Tactile-kinaesthetic and Oral sensorimotor Stimulation
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Feeding and Eating Disorders focused on measuring preterm infants, high-risk newborns, congenital diaphragmatic hernia, autonomous nervous system, tactile stimulation

Eligibility Criteria

undefined - 2 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Preterm birth at gestational age < 30 weeks or Diagnosis of Congenital Diaphragmatic Hernia Born at Amalia Children's Hospital or admitted 1rst day of life Written informed consent of both parents or representatives Exclusion Criteria: Preterm infant born at gestational age ≥ 30 weeks Perinatal Asphyxia; (Apgar score at 5' < 5 and first pH ≤ 7,0) Major congenital anomalies or birth defects other than congenital diaphragmatic hernia; Metabolic disease that necessitates a special diet other than human milk or formula feeding and or has a prognosis of impaired neurological development Parental refusal of participation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Standard care

    Standard care supplemented with HAPTOS intervention

    Arm Description

    Will receive standard of care according to the institutional protocol and principles of developmental care which currently belongs to (inter-) national guidelines and is regarded as safe.

    Will receive standard of care according to the principles of developmental care which currently belongs to (inter-) national guidelines plus HAPTOS intervention which includes: tactile/ kinaesthetic massage of the trunk and extremities twice daily and stimulation of oral function by providing perioral stimulation up to 4 times a day. Interventions will be continued until clinical improvement.

    Outcomes

    Primary Outcome Measures

    Number of days to achieve full enteral feeding
    measuring the time from birth until enteral intake reaches 150ml/kg/d
    Postmenstrual age at achievement of full oral feeding
    Number of postmenstrual weeks until gastrointestinal tube is taken out

    Secondary Outcome Measures

    First meconium passage
    Postnatal day at first meconium
    Duration of meconium passage
    Number of days until normal defecation
    Use of laxatives
    Number of laxatives given
    Gastrointestinal Motility
    Volume of gastric residuals per week
    Vomiting
    Number of incidences of vomiting in combination with aspiration
    Periodic breathing
    Number of desaturations < 80% and/or bradycardia < 80/min that require intervention per week
    Feeding difficulties
    Number of infants with impaired oral motor skills
    Maturation of heart rate variability
    Number of infants with delayed regulation of the para- and sympathicus tonus measured continuously through monitordata collection
    Growth at postmenstrual age
    Gain in weight, length, and head circumference including percentiles
    Morbidity
    Number of infants with necrotizing enterocolitis, spsis, chronic lung disease, retinopathy of prematurity, intra-ventricular hemorrhage
    Duration hospital stay
    Postnatal age at time of discharge home
    Neurocognitive development
    Measuring cognitive and motor development using Bayley Scores of Infant Development (BSID III)
    Parent participation in care
    Measuring number of parents who participate and frequency of activity

    Full Information

    First Posted
    June 21, 2023
    Last Updated
    September 21, 2023
    Sponsor
    Radboud University Medical Center
    Collaborators
    Nutricia Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06057415
    Brief Title
    Improving Gastrointestinal Function In High-Risk Newborns By Stimulation Of The Enteric Nervous System
    Acronym
    NeoHemoHapt
    Official Title
    Improving Gastrointestinal Function In High-Risk Newborns By Stimulation Of The Enteric Nervous System
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2024 (Anticipated)
    Primary Completion Date
    December 31, 2025 (Anticipated)
    Study Completion Date
    July 1, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Radboud University Medical Center
    Collaborators
    Nutricia Research

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The goal of this therapeutical intervention trial is to investigate whether tactile-kinesthaetic and oral sensorimotor stimulation can improve gastrointestional function in preterm infants born before gestational age of 30 weeks and newborns with congenital diaphragmatic hernia. The main question it aims to answer is: • To determine whether HAPTOS- intervention (Handling Adapted to Postnatal age with Tactile-kinaesthetic and Oral sensorimotor Stimulation) in the particpants results in earlier attainment (postnatal days) of full enteral feeding and/or full oral feeding (post menstrual age) compared to standard care. Researchers will compare an intervention group receiving standard of care plus HAPTOS intervention to a group of patients receiving only current standard of care.
    Detailed Description
    Infants born preterm or with congenital diaphragmatic hernia (CDH) are at risk for several long-term unfavourable outcomes that can be related to feeding difficulties from birth onwards. Adverse nutritional outcomes in both patient groups mainly originate from mechanical dysfunction, based on dysmotility. Mechanical function includes suck-swallow coordination, gastrointestinal sphincter tone, gastric emptying and intestinal motility and is regulated by the complex interplay of the autonomic (ANS) and enteric (ENS) nervous system with modulation by the central nervous system (CNS). The intra-uterine environment provides the fetus with developmentally timed sensory exposures through 'touch' that are necessary for development of sensory control and autonomous coordination of bodily functions. Preterm infants miss out this normal maturation, while newborns with CDH may exhibit a delayed maturation probably as a result of the deviant anatomical situation and the severe illness during the direct postnatal period. In the postnatal situation both patient groups may be confronted with either 'negative' sensory stimulation through exposures such as procedural touch/handling, pain or otherwise a reduction in sensory exposures through avoidance of positive touch in relation to supposed clinical instability. All together this may affect normal development and may lead to sensory deprivation and delayed maturation of the nervous regulation and cerebral maturation. Tactile-kinaesthetic and oral sensorimotor stimulation using positive gentle touch have been shown to positively affect cardiorespiratory stability, weight gain, gastro-intestinal performance, and length of stay in hospital for preterm infants. However, these strategies have not been evaluated in high-risk infants. The current study aims at evaluating an intervention programme that provides positive stimuli through touch adapted to the stage of development of the infant with regard to timing, duration and intensity that supports the maturational development of gastrointestinal functionality. (Handling Adapted to Postnatal age with Tactile-kinaesthetic and Oral sensorimotor Stimulation; HAPTOS intervention). We hypothesize that the HAPTOS intervention will improve the postnatal maturation of the autonomous and enteral nervous system and cause improvements in gastrointestinal motility, enteral and oral feeding and cardiorespiratory stability.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Feeding and Eating Disorders
    Keywords
    preterm infants, high-risk newborns, congenital diaphragmatic hernia, autonomous nervous system, tactile stimulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The randomization will occur web-based, and will be protected from selection bias by using concealed, stratified and blocked randomization. The group of preterm infants will randomly be assigned to 2 treatment groups according to 6 strata. Gestational age 24+0 - 26+0 weeks + Appropriate for gestational age (AGA) Gestational age 24+0 - 26+0 weeks + Small for gestational age (SGA) Gestational age 26+1 - 28+0 weeks + AGA Gestational age 26+1 - 28+0 weeks + SGA Gestational age 28+1 - 29+6 weeks + AGA Gestational age 28+1 - 29+6 weeks + SGA
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard care
    Arm Type
    No Intervention
    Arm Description
    Will receive standard of care according to the institutional protocol and principles of developmental care which currently belongs to (inter-) national guidelines and is regarded as safe.
    Arm Title
    Standard care supplemented with HAPTOS intervention
    Arm Type
    Experimental
    Arm Description
    Will receive standard of care according to the principles of developmental care which currently belongs to (inter-) national guidelines plus HAPTOS intervention which includes: tactile/ kinaesthetic massage of the trunk and extremities twice daily and stimulation of oral function by providing perioral stimulation up to 4 times a day. Interventions will be continued until clinical improvement.
    Intervention Type
    Procedure
    Intervention Name(s)
    HAPTOS (Handling Adapted to Postnatal age with Tactile-kinaesthetic and Oral sensorimotor Stimulation
    Intervention Description
    Tactile-kinaesthetic and Oral sensorimotor Stimulation
    Primary Outcome Measure Information:
    Title
    Number of days to achieve full enteral feeding
    Description
    measuring the time from birth until enteral intake reaches 150ml/kg/d
    Time Frame
    60 days
    Title
    Postmenstrual age at achievement of full oral feeding
    Description
    Number of postmenstrual weeks until gastrointestinal tube is taken out
    Time Frame
    52 weeks
    Secondary Outcome Measure Information:
    Title
    First meconium passage
    Description
    Postnatal day at first meconium
    Time Frame
    14 days
    Title
    Duration of meconium passage
    Description
    Number of days until normal defecation
    Time Frame
    14 days
    Title
    Use of laxatives
    Description
    Number of laxatives given
    Time Frame
    60 days
    Title
    Gastrointestinal Motility
    Description
    Volume of gastric residuals per week
    Time Frame
    100 days
    Title
    Vomiting
    Description
    Number of incidences of vomiting in combination with aspiration
    Time Frame
    duration of hospitalization up to 15 months
    Title
    Periodic breathing
    Description
    Number of desaturations < 80% and/or bradycardia < 80/min that require intervention per week
    Time Frame
    duration of hospitalization up to 15 months
    Title
    Feeding difficulties
    Description
    Number of infants with impaired oral motor skills
    Time Frame
    24 months
    Title
    Maturation of heart rate variability
    Description
    Number of infants with delayed regulation of the para- and sympathicus tonus measured continuously through monitordata collection
    Time Frame
    duration of intensive care stay up to 60 days
    Title
    Growth at postmenstrual age
    Description
    Gain in weight, length, and head circumference including percentiles
    Time Frame
    at 40 weeks, 3, 6, 12, 18 and 24 weeks
    Title
    Morbidity
    Description
    Number of infants with necrotizing enterocolitis, spsis, chronic lung disease, retinopathy of prematurity, intra-ventricular hemorrhage
    Time Frame
    100 days
    Title
    Duration hospital stay
    Description
    Postnatal age at time of discharge home
    Time Frame
    100 days
    Title
    Neurocognitive development
    Description
    Measuring cognitive and motor development using Bayley Scores of Infant Development (BSID III)
    Time Frame
    at 24 months
    Title
    Parent participation in care
    Description
    Measuring number of parents who participate and frequency of activity
    Time Frame
    duration of hospitalization up to 100 days

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    2 Days
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Preterm birth at gestational age < 30 weeks or Diagnosis of Congenital Diaphragmatic Hernia Born at Amalia Children's Hospital or admitted 1rst day of life Written informed consent of both parents or representatives Exclusion Criteria: Preterm infant born at gestational age ≥ 30 weeks Perinatal Asphyxia; (Apgar score at 5' < 5 and first pH ≤ 7,0) Major congenital anomalies or birth defects other than congenital diaphragmatic hernia; Metabolic disease that necessitates a special diet other than human milk or formula feeding and or has a prognosis of impaired neurological development Parental refusal of participation
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yvet Kroeze
    Phone
    +31 (0)24 36 55 700
    Email
    clinicalstudiesteamvrouwkind@radboudumc.nl
    First Name & Middle Initial & Last Name or Official Title & Degree
    Viola Christmann, MD,PhD
    Email
    viola.christmann@radboudumc.nl
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Viola Christmann, MD, PhD
    Organizational Affiliation
    Radboud University Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Improving Gastrointestinal Function In High-Risk Newborns By Stimulation Of The Enteric Nervous System

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