Investigate the effect of acidic and neutral oligosaccharides supplemented enteral nutrition on infectious morbidity, feeding tolerance and short-term outcome in VLBW infants. Furthermore, an attempt is made to elucidate the role of acidic and…
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
- Bacterial infectious disorders
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine the effect of acidic and neutral oligosaccharides supplemented
enteral nutrition on infectious morbidity, intestinal microflora, feeding
tolerance, and short-term outcome in VLBW infants.
Secondary outcome
1. To elucidate the role of acidic oligosaccharides in modulation of the immune
response and postnatal adaptation of the gut.
2. To determine the long term effects of acidic and neutral oligosaccharides
supplemented enteral nutrition in the neonatal period on the development of
allergic and infectious disease in the first years of life (by questionnaire)
and neurodevelopmental outcome, neuromotor development at the corrected age of
1 and 2 years and mental/motor development (BSIDII) at the corrected age of 2
years (as part of the regular follow-up of NICU infants).
3. To determine the effect of acidic and neutral oligosaccharides supplemented
enteral nutrition on the response to immunizations with
Diphteria-Tetanus-acellular pertussis-inactivated polio-Haemophilus influenzae
type B-Pneumococ (DTaP-IPV-HIB-Pneu) vaccins (initial 3 doses), and booster
immunization (4th dose). In infants with parents from endemic Hepatitis B parts
of the world and in infants born to Hepatitis B positive mothers, the response
to immunization with Hepatitis B vaccin will also be evaluated.
4. To determine the transplacental transport of IgG against Measles, Diphteria,
Tetanus, Pertussis, Polio, Haemophilus Influenzae type B, Pneumococcus, Mumps,
Rubella and Hepatitis B in preterm infants.
5. To deteremine physiological variations of blood IL6 (arterial, venous,
capillar) in preterm infants.
Background summary
Prevention of serious infections in very low birth weight (VLBW) infants is a
challenge, since prematurity and low birth weight often require many
interventions and high utility of devices. Furthermore, administration of
enteral nutrition is limited by immaturity of the gastrointestinal tract. The
acid and neutral oligosaccharides plays an important role in the development of
the intestinal bacterial colonization and functional integrity of the gut. In
preterm infants, the intestinal bacterial colonization is delayed compared with
term infants with possible negative effects on susceptibility to serious
infections. An abnormal intestinal bacterial colonization may also have
negative effects on functional integrity of the gut and may lead to
immunosuppression.
Study objective
Investigate the effect of acidic and neutral oligosaccharides supplemented
enteral nutrition on infectious morbidity, feeding tolerance and short-term
outcome in VLBW infants. Furthermore, an attempt is made to elucidate the role
of acidic and neutral oligosaccharides supplemented enteral nutrition in
postnatal adaptation of the gut and modulation of the immune response.
Study design
Double blind placebo-controlled randomised controlled trial whereby between
days 3 and 30 of life, acidic and neutral oligosaccharides supplementation
(20/80 mixture) is administered in a maximum dose of 1.5 g/kg/day to
breastfeeding or preterm formula in the intervention group.
Interventions:
Enteral acidic and neutral oligosaccharides supplementation
Registration daily amount of feedings
Registration of perinatal data, clinical relevant data as severe infections,
respiratory support, admission time.
Additional research:
< 48 uur:
- blood for cytokine profiles and IgG measurement
- faecal samples for FISH, pH, faecal calprotectin/IL-8
- sugarabsorptiontest
- blood for IgG measurement
Day 4:
- sugarabsorptiontest
Day 7:
- blood for cytokine profiles
- faecal samples for FISH, pH, faecal calprotectin/IL-8
- sugarabsorptiontest
Day 14:
- blood for cytokine profiles
- faecal samples for FISH, pH, faecal calprotectin/IL-8
- gastrointestinal transport time
Day 30:
- faecal samples for FISH, pH, faecal calprotectin/IL-8
Month 5:
- blood for immune response and IgE/IgG4
- faecal samples for FISH, pH, faecal calprotectin/IL-8
1 year:
- blood for immune response and IgE/IgG4
- faecal samples for FISH, pH, faecal calprotectin/IL-8
* At one timepoint in the first month in a subgroup of 20 preterm infants blood
for physiological variations of blood cytokines (IL6) (0,2ml blood)
* At one timepoint in a subgroup of 20 healthy adults blood for physiological
variations of blood cytokines in venous (1ml) and capillary blood 0,5ml
For IgE/IgG4 0,6ml blood is needed, for cytokine profiles ca 0.5ml, for immune
response 2ml.
To measure the response to vaccinations bloodsamples will be taken at patients
home or during regular hospital visits. To determine the frequency of
side-effects of immunizations, standardized questionnaires will be given to the
parents at the time of immunizations.
The development of allergic and infectious disease in the first years of life
(by questionnaire) and neurodevelopmental outcome, neuromotor development at
the corrected age of 1 and 2 years and mental/motor development (BSIDII) at the
corrected age of 2 years (as part of the regular follow-up of NICU infants)
will be measured.
Intervention
Between days 3 and 30 of life, acidic and neutral oligosaccharides (20/80
mixture)supplementation is administered in a dose 1,5 g/kg/day to breastfeeding
or preterm formula in the intervention group.
Study burden and risks
The pedatrician is responsible in making any descisions about doing the tests.
Sampling of faeces will be done during regular care times. Extra bloodsamples
will be taken during regular intravenous sampling times and if possible from
intravenous lines.
Previous research has shown that enteral supplemented acidic and neutral
oligosaccharides to premature infants cause no extra risks.
Previous research has shown that the sugarabsorptiontest causes no extra
burdening for the patients.
See also study design
Postbus 7057
1007 MB Amsterdam
NL
Postbus 7057
1007 MB Amsterdam
NL
Listed location countries
Age
Inclusion criteria
1. Written an informed consent from both parents or a legal guardians
2. Infants born with a gestational age of less than 32 weeks and/or a birthweight of less than 1500 gram
Exclusion criteria
1. Severe congenital disorders, like cardiac disorders, syndromal disorders, immunodeficiency disorders
2. Congenital disorders of the gastrointestinal tract
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ISRCTN | ISRCTN16211826 |
| CCMO | NL14256.029.07 |