Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||N/A - 44 Weeks|
Inclusion Criteria:All of the following must be met: 1. Current weight greater than ≥ 1.5kg (this will reduce to current weight of ≥ 1.0kg following midpoint review if no safety concerns. 2. Deemed by attending clinician that fortification of breast milk is desirable either to meet nutritional requirements or optimise growth. 3. Exclusive maternal or donor breast milk feeding (at time of starting fortifier) 4. At least one of the following diagnostic criteria: 1. Any previous gastrointestinal tract surgery. This may include but is not limited:
- - Surgery for NEC.
- - Gastroschisis.
- - Spontaneous Intestinal Perforation.
- - Intestinal Atresias and Webs.
- - Malrotation.
- - Hirschsprung's disease.
- - Volvulus.
- - Exomphalos.
- - Meconium Ileus/plugs.
- - Anorectal anomalies.
Exclusion Criteria:Any of the following will result in exclusion: 1. Known congenital metabolic disorder. 2. Formula fed prior to diagnosis being made. 3. Bilateral grade III or IV intra-ventricular haemorrhage. 4. Any infant who has had gastrointestinal tract surgery and received feed other than breast milk following surgery and prior to commencing the study. 5. Refusal of consent, refusal for the use of pasteurised donor human milk. The reason for these exclusion criteria is to exclude any baby in whom the primary outcome may be adversely influenced by co-existing medical morbidities
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|University Hospital Southampton NHS Foundation Trust|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Mark Johnson, PhD|
|Principal Investigator Affiliation||University Hospital Southampton NHS Foundation Trust|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|NEC, Gastroschisis, Intestinal Perforation, Atresia, Intestinal, Hirschsprung Disease, Exomphalos, Volvulus, Anorectal Malformations, Meconium Ileus, Cows Milk Allergy, Preterm|
BACKGROUND There is an increasing body of evidence to support a causal link between ingestion of cow's milk protein (CMP) containing milks and the development of gastrointestinal disturbance in preterm and term infants. In particular the development of necrotising enterocolitis (NEC) has been associated with use of CMP containing feed in both epidemiological studies and a small number of prospective trials. It may be that this is due to a lack of the protective effect of breast milk, rather than CMP pe se. In addition to NEC, CMP containing feed may be implicated in the development of other gastrointestinal disturbance in preterm infants and as such many clinicians avoid the use of CMP containing feed in high risk infants. One such group are preterm infants who have already had an episode of NEC. Others include those born with a congenital anomaly of the gastrointestinal tract such as gastroschisis. One of the great challenges in the care of the preterm neonate is the delivery of adequate nutritional intake to support growth and development. Whilst there are recognised benefits of human milk for preterm infants, a diet of exclusive human milk does not meet the nutritional and metabolic demands of the preterm infant(4). To close this nutritional gap, breast milk fortifier (BMF) is typically added to human milk. BMF is manufactured from cow's milk, and so contains hydrolysed CMP. However, there is concern that this addition of BMF may be associated with gastrointestinal disturbance, and this may be due to the fact that it contains elements of CMP. In view of this potential association, there is an understandable reluctance to use standard BMF in infants who have already had evidence of gastrointestinal disturbance, such as NEC or gastrointestinal surgery. RATIONALE Recently a human milk based breast milk fortifier (NeoKare) has become available and is currently being evaluated in the preterm population when compared to current standard feeding practice. Provision of such an exclusive human milk diet may not carry the same risk of gastrointestinal disturbance and may represent an opportunity for high-risk preterm infants that have had NEC, undergone gastrointestinal surgery or had other gastrointestinal disturbance felt to be related to type of milk, to receive the benefits of human milk together with the nutritional benefits of milk fortification, whilst minimising the risks reported to be associated with exposure to CMP. Being able to improve nutrient intakes in this way using human milk based fortifier, may reduce the need for parenteral nutrition, and in turn reduce the risk of complications of parenteral nutrition, length of stay and hospital costs. To date this human milk-based breast milk fortifier has not been formally evaluated in this group of infants. There is a need to establish if NeoKare is tolerated by infants with pre-existing gastrointestinal disturbance, and see if it can be safely used in this population. There is also a need to see if it enables better nutrition and growth, and earlier cessation of PN, and in turn a shorter length of stay, These may have cost related benefits, which also need to be explored. Primary objective The primary aim of the study is to investigate the tolerability of a powdered human milk-based breast milk fortifier (Neokare) in infants cared for on a neonatal unit with pre-existing gastrointestinal disturbance (previous gastrointestinal surgery, medically treated gastrointestinal disease, previously suspected intolerance of cow's milk protein-based breast milk fortifier in the absence of other gastrointestinal disease or a congenital gastrointestinal anomaly not requiring surgery). This will be compared to a retrospective control group of similar infants born prior to the study who were not managed using the NeoKare product. Secondary objectives The main secondary aim of the study is to investigate the safety of a powdered human milk-based breast milk fortifier (Neokare) in infants cared for on a neonatal unit with pre-existing gastrointestinal disturbance (previous gastrointestinal surgery, medically treated gastrointestinal disease, previously suspected intolerance of cow's milk protein-based breast milk fortifier in the absence of other gastrointestinal disease or a congenital gastrointestinal anomaly not requiring surgery) This will be compared to a retrospective control group of similar infants born prior to the study who were not managed using the NeoKare product Other secondary aims of the study are to see if, in infants cared for on a neonatal unit with pre-existing gastrointestinal disturbance (previous gastrointestinal surgery, medically treated gastrointestinal disease, previously suspected intolerance of cow's milk protein-based breast milk fortifier in the absence of other gastrointestinal disease or a congenital gastrointestinal anomaly not requiring surgery), the use of a powdered human milk-based breast milk fortifier (Neokare) leads to improvements in growth, nutrition, length of stay, time on parenteral nutrition and other clinical outcomes compared to a retrospective control group of similar infants born prior to the study who were not managed using the NeoKare product. Cost of care will also be compared. TRIAL DESIGN This will be a Prospective observational cohort study with a retrospective control group
: Breast Milk Fortification with NeoKare
Prospective cohort, 50 infants
: No Breast Milk Fortification
Retrospective, historical cohort, approx 50 infants
Other: - NeoKare Breast Milk Fortifier
Powdered product made from human breast milk used to increase nutritional content of mother's own breast milk
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