Neonatal SEPSISNCT03498989
Effect of Early Feeding of Breast Milk
A study testing preterm formula milk and exclusive breast milk in people with Neonatal SEPSIS and Weight Gain, run by Assiut University.
Trial summary
Breast milk is an extremely complex and highly variable biofliud that has evolved to nourish infants and protect them from disease whilst their own immune system matures. The composition of human breast milk changes in response to many factors, matching the infants requirement according to its age and other… Read more about this study
- Who is it for?
- Ages 1 week to 1 month
- Conditions the study is for
- Neonatal SEPSIS, Weight Gain, Feeding Disorder Neonatal
- What is being tested?
- preterm formula milk and exclusive breast milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 21 Jun 2018to 21 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 1 week to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age <37 weeks.
- Birth weight >1000 gm.
Who cannot join
- Gestational age 37 weeks.
- Birth weight < 1000 gm.
- Newborns with congenital anomalies.
- Newborns with suspected metabolic diseases.
- Newborns on mechanical ventilators.
- Newborns with suspected neonatal sepsis.
About this study
Official title: Effect of Early Feeding of Breast Milk Versus Formula Milk on Health Status of Preterm
Breast milk is an extremely complex and highly variable biofliud that has evolved to nourish infants and protect them from disease whilst their own immune system matures. The composition of human breast milk changes in response to many factors, matching the infants requirement according to its age and other characteristics.
Read the detailed description
Breast milk is an extremely complex and highly variable biofliud that has evolved to nourish infants and protect them from disease whilst their own immune system matures. The composition of human breast milk changes in response to many factors, matching the infants requirement according to its age and other characteristics.
Therefore, the composition of breast milk is widely believed to be specifically tailored by each mother to precisely reflect the requirements of her infant.
Human milk is uniquely suited to the human infant, both in its nutritional composition and in the non-nutritive bioactive factors that promote survival and healthy development.
Breast milk contains over 400 different proteins which perform a variety of functions; providing nutrition, possessing antimicrobial and immunomodulatory activities, as well as stimulating the absorption of nutrients.
The immune system of preterm infants is immature, placing them at increased risk for serious immune-related complications.
Human milk provides a variety of immune protective and immune maturation factors that are beneficial to the preterm infants poorly developed immune system. The most studied immune components in human milk include antimicrobial proteins, maternal leukocytes, immunoglobulins, cytokines and chemokines, oligosaccharides, gangliosides, nucleotides, and long-chain polyunsaturated fatty acids. There is growing evidence that these components contribute to the lower incidence of immune-related conditions in the preterm infant. Therefore, provision of these components in human milk, donor milk, or formula may provide immunologic benefits.
The effects of breast milk and breastfeeding on neurodevelopment may be quite different in very preterm infants than in those born at full term. Nutritionally, breast milk is considered the optimal food for full term infants. But preterm infants require fortification to match third trimester nutrient accretion rates.
- Conditions
- Neonatal SEPSIS, Weight Gain, Feeding Disorder Neonatal
- Being tested
- preterm formula milk, exclusive breast milk
- Medical subject headings
- Neonatal Sepsis, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preterm formula milkOther
- complete blood picture
- C-reactive protein
- Serum electrolytes
- Plain x-ray and abdominal ultrasound.
exclusive breast milkOther
exclusive breast milk
| Study group | Role | What they receive |
|---|---|---|
| preterm formula milk neoborn | Experimental | will be given preterm formula milk Receives: Other: preterm formula milk |
| exclusive breast milk | Experimental | will be given exclusive breast milk Receives: Other: exclusive breast milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain
All newborn well examine regards weight
- Necrotizing enterocolitis.
- Neonatal Sepsis.
- Weight gain.
- Feeding tolerance
Measured: 1 year
Number of participants with complete blood pictures
All newborn are examine
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start21 Jun 2018 (estimated)
- Primary completion21 Mar 2019 (estimated)
- Study completion21 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neonatal SEPSISStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AATaha, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03498989
- Sponsor's protocol ID
- Effect of early feeding
- Status last verified
- Mar 2018
- First submitted
- 21 Mar 2018
- Last updated
- 17 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fujita M, Roth E, Lo YJ, Hurst C, Vollner J, Kendell A. In poor families, mothers' milk is richer for daughters than sons: a test of Trivers-Willard hypothesis in agropastoral settlements in Northern Kenya. Am J Phys Anthropol. 2012 Sep;149(1):52-9. doi: 10.1002/ajpa.22092. Epub 2012 May 24.
PubMed 22623326Molinari CE, Casadio YS, Hartmann BT, Livk A, Bringans S, Arthur PG, Hartmann PE. Proteome mapping of human skim milk proteins in term and preterm milk. J Proteome Res. 2012 Mar 2;11(3):1696-714. doi: 10.1021/pr2008797. Epub 2012 Feb 22.
PubMed 22309230
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Feeding of Breast Milk Versus Formula Milk on Health Status of Preterm
- ClinicalTrials.gov ID
- NCT03498989
- Acronym / sponsor ID
- Effect of early feeding
- Conditions
- Neonatal SEPSIS, Weight Gain, Feeding Disorder Neonatal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 21 Jun 2018 (estimated)
- Primary completion
- 21 Mar 2019 (estimated)
- Study completion
- 21 Feb 2020 (estimated)
- First posted
- 17 Apr 2018 (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.
Breast milk is an extremely complex and highly variable biofliud that has evolved to nourish infants and protect them from disease whilst their own immune system matures. The composition of human breast milk changes in response to many factors, matching the infants requirement according to its age and other characteristics.
Detailed description
Breast milk is an extremely complex and highly variable biofliud that has evolved to nourish infants and protect them from disease whilst their own immune system matures. The composition of human breast milk changes in response to many factors, matching the infants requirement according to its age and other characteristics.
Therefore, the composition of breast milk is widely believed to be specifically tailored by each mother to precisely reflect the requirements of her infant.
Human milk is uniquely suited to the human infant, both in its nutritional composition and in the non-nutritive bioactive factors that promote survival and healthy development.
Breast milk contains over 400 different proteins which perform a variety of functions; providing nutrition, possessing antimicrobial and immunomodulatory activities, as well as stimulating the absorption of nutrients.
The immune system of preterm infants is immature, placing them at increased risk for serious immune-related complications.
Human milk provides a variety of immune protective and immune maturation factors that are beneficial to the preterm infants poorly developed immune system. The most studied immune components in human milk include antimicrobial proteins, maternal leukocytes, immunoglobulins, cytokines and chemokines, oligosaccharides, gangliosides, nucleotides, and long-chain polyunsaturated fatty acids. There is growing evidence that these components contribute to the lower incidence of immune-related conditions in the preterm infant. Therefore, provision of these components in human milk, donor milk, or formula may provide immunologic benefits.
The effects of breast milk and breastfeeding on neurodevelopment may be quite different in very preterm infants than in those born at full term. Nutritionally, breast milk is considered the optimal food for full term infants. But preterm infants require fortification to match third trimester nutrient accretion rates.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preterm formula milk neoborn | Experimental | Other: preterm formula milkwill be given preterm formula milk |
| exclusive breast milk | Experimental | Other: exclusive breast milkwill be given exclusive breast milk |
Who may qualify
- Ages
- 1 week to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Gestational age <37 weeks.
- Birth weight >1000 gm.
Key exclusion criteria (6 listed)
- Gestational age 37 weeks.
- Birth weight < 1000 gm.
- Newborns with congenital anomalies.
- Newborns with suspected metabolic diseases.
- Newborns on mechanical ventilators.
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 |
|---|---|---|
| preterm formula milkA. complete blood picture B. C-reactive protein C. Serum electrolytes D. Plain x-ray and abdominal ultrasound. | Other | preterm formula milk neoborn |
| exclusive breast milkexclusive breast milk | Other | exclusive breast milk |
Primary outcome
Weight gain
Time frame: 1 year
All newborn well examine regards weight 1. Necrotizing enterocolitis. 2. Neonatal Sepsis. 3. Weight gain. 4. Feeding tolerance
Number of participants with complete blood pictures
Time frame: 1 year
All newborn are examine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Background: PubMed 22623326Fujita M, Roth E, Lo YJ, Hurst C, Vollner J, Kendell A. In poor families, mothers' milk is richer for daughters than sons: a test of Trivers-Willard hypothesis in agropastoral settlements in Northern Kenya. Am J Phys Anthropol. 2012 Sep;149(1):52-9. doi: 10.1002/ajpa.22092. Epub 2012 May 24.
- Background: PubMed 22309230Molinari CE, Casadio YS, Hartmann BT, Livk A, Bringans S, Arthur PG, Hartmann PE. Proteome mapping of human skim milk proteins in term and preterm milk. J Proteome Res. 2012 Mar 2;11(3):1696-714. doi: 10.1021/pr2008797. Epub 2012 Feb 22.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing preterm formula milk and exclusive breast milk in people with Neonatal SEPSIS and Weight Gain, run by Assiut University.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight gain (time frame: 1 year). 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?
On the ClinicalTrials.gov record for NCT03498989, which also lists 2 linked publications.
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 17 Apr 2018.