Feeding and Eating DisordersNeoHemoHaptNCT06057415
Improving Gastrointestinal Function In High-Risk Newborns By Stimulation Of The Enteric Nervous System
A study testing HAPTOS (Handling Adapted to Postnatal age with Tactile-kinaesthetic and Oral sensorimotor Stimulation in people with Feeding and Eating Disorders, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 2 days
- Conditions the study is for
- Feeding and Eating Disorders
- What is being tested?
- HAPTOS (Handling Adapted to Postnatal age with Tactile-kinaesthetic and Oral sensorimotor Stimulation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Jun 2024to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Viola Christmann, MD,PhD contact
Netherlands1 site, 1 recruiting
- Recruiting
Radboud University Nijmegen Medical Centre
Nijmegen, 6500 HB
V Christmann, dr., 0031243613936, v.christmann@radboudumc.nl
M Nelissen, MSc, 0031630368351, m.nelissen@radboudumc.nl
About this study
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.
Read the 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.
- Conditions
- Feeding and Eating Disorders
- Being tested
- HAPTOS (Handling Adapted to Postnatal age with Tactile-kinaesthetic and Oral sensorimotor Stimulation
- Keywords
- preterm infants, high-risk newborns, congenital diaphragmatic hernia, autonomous nervous system, tactile stimulation
- Medical subject headings
- Feeding and Eating Disorders, Hernias, Diaphragmatic, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAPTOS (Handling Adapted to Postnatal age with Tactile-kinaesthetic and Oral sensorimotor StimulationProcedure or surgery
Tactile-kinaesthetic and Oral sensorimotor Stimulation
| Study group | Role | What they receive |
|---|---|---|
| Standard care | No intervention | 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. |
| Standard care supplemented with HAPTOS intervention | Experimental | 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. Receives: Procedure: HAPTOS (Handling Adapted to Postnatal age with Tactile-kinaesthetic and Oral sensorimotor Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days to achieve full enteral feeding
measuring the time from birth until enteral intake reaches 150ml/kg/d
Measured: 60 days
Postmenstrual age at achievement of full oral feeding
Number of postmenstrual weeks until gastrointestinal tube is taken out
Measured: 52 weeks
Secondary outcomes (13)
First meconium passage
Postnatal day at first meconium
Measured: 14 days
Duration of meconium passage
Number of days until normal defecation
Measured: 14 days
Use of laxatives
Number of laxatives given
Measured: 60 days
Gastrointestinal Motility
Volume of gastric residuals per week
Measured: 100 days
Vomiting
Number of incidences of vomiting in combination with aspiration
Measured: duration of hospitalization up to 15 months
Periodic breathing
Number of desaturations < 80% and/or bradycardia < 80/min that require intervention per week
Measured: duration of hospitalization up to 15 months
Feeding difficulties
Number of infants with impaired oral motor skills
Measured: 24 months
Maturation of heart rate variability
Number of infants with delayed regulation of the para- and sympathicus tonus measured continuously through monitordata collection
Measured: duration of intensive care stay up to 60 days
Growth at postmenstrual age
Gain in weight, length, and head circumference including percentiles
Measured: at 40 weeks, 3, 6, 12, 18 and 24 weeks
Morbidity
Number of infants with necrotizing enterocolitis, spsis, chronic lung disease, retinopathy of prematurity, intra-ventricular hemorrhage
Measured: 100 days
Duration hospital stay
Postnatal age at time of discharge home
Measured: 100 days
Neurocognitive development
Measuring cognitive and motor development using Bayley Scores of Infant Development (BSID III)
Measured: at 24 months
Parent participation in care
Measuring number of parents who participate and frequency of activity
Measured: duration of hospitalization up to 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start10 Jun 2024
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding and Eating DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Nutricia Research
- Responsible party
- Sponsor
- Investigators
- Viola Christmann, MD, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057415
- Sponsor's protocol ID
- 114536
- Acronym
- NeoHemoHapt
- Status last verified
- Jun 2024
- First submitted
- 21 Jun 2023
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Gastrointestinal Function In High-Risk Newborns By Stimulation Of The Enteric Nervous System
- ClinicalTrials.gov ID
- NCT06057415
- Acronym / sponsor ID
- NeoHemoHapt / 114536
- Conditions
- Feeding and Eating Disorders
- Keywords
- preterm infants, high-risk newborns, congenital diaphragmatic hernia, autonomous nervous system, tactile stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Nutricia Research
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | –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. |
| Standard care supplemented with HAPTOS intervention | Experimental | Procedure: HAPTOS (Handling Adapted to Postnatal age with Tactile-kinaesthetic and Oral sensorimotor StimulationWill 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. |
Who may qualify
- Ages
- Up to 2 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HAPTOS (Handling Adapted to Postnatal age with Tactile-kinaesthetic and Oral sensorimotor StimulationTactile-kinaesthetic and Oral sensorimotor Stimulation | Procedure or surgery | Standard care supplemented with HAPTOS intervention |
Primary outcome
Number of days to achieve full enteral feeding
Time frame: 60 days
measuring the time from birth until enteral intake reaches 150ml/kg/d
Postmenstrual age at achievement of full oral feeding
Time frame: 52 weeks
Number of postmenstrual weeks until gastrointestinal tube is taken out
13 secondary outcomes
First meconium passage
Time frame: 14 days
Duration of meconium passage
Time frame: 14 days
Use of laxatives
Time frame: 60 days
Gastrointestinal Motility
Time frame: 100 days
Vomiting
Time frame: duration of hospitalization up to 15 months
Periodic breathing
Time frame: duration of hospitalization up to 15 months
Feeding difficulties
Time frame: 24 months
Maturation of heart rate variability
Time frame: duration of intensive care stay up to 60 days
Growth at postmenstrual age
Time frame: at 40 weeks, 3, 6, 12, 18 and 24 weeks
Morbidity
Time frame: 100 days
Duration hospital stay
Time frame: 100 days
Neurocognitive development
Time frame: at 24 months
Parent participation in care
Time frame: duration of hospitalization up to 100 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Viola Christmann, MD,PhD contact
Viola Christmann, MD, PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HAPTOS (Handling Adapted to Postnatal age with Tactile-kinaesthetic and Oral sensorimotor Stimulation in people with Feeding and Eating Disorders, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yvet Kroeze (+31 (0)24 36 55 700, pediatricresearchunit@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days to achieve full enteral feeding (time frame: 60 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.