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Neonatal InfectionNeoInnateNCT03353051

Iron and Infection: Neonatal Nutritional Immunity

An observational study of Neonatal Infection and Nutritional Anemia, run by London School of Hygiene and Tropical Medicine at 1 site in The Gambia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The motivation for this study was produced from our preliminary data, which showed that during the first 96 hours of life a full-term neonate will actively reduce the overall serum iron concentration of their blood and the transferrin saturation decreases rapidly from 45% in cord blood to ~20% by six hours… Read more about this study

Who is it for?
Ages 5 minutes to 28 days
Conditions the study is for
Neonatal Infection, Nutritional Anemia
What is being tested?
Observational study
How many people
430 participants
Where
1 siteThe Gambia
Study dates
25 Jul 2017to 3 Apr 2019
Phase
Observational
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 5 minutes to 28 days
  • All sexes
  • Child

Study population: All neonates will be born at Serrekunda Hospital, The Gambia. New Ballard score is only measure used to evaluate gestational age Preterm neonates with Low Birth Weight (PTB with LBW) (Group A): Neonates will not be recruited directly into this group. These medical stable neonates will weigh <2500g and also be <37 weeks of gestational age. Preterm (PTB) neonates (Group B): Medical stable neonates between >32 and <37 weeks' gestational age. PTB neonates will weigh >2500g. Low Birth Weight (LBW) neonates (Group C): Medical stable neonates with weight equal to or >2000g and <2500g. LBW neonates will have a gestational age of >32 weeks. Full Term (FT) neonates (Group D1-D3): All healthy FT neonates will weigh ≥2500g with gestational age ≥37 weeks.

Who may be able to join

  • Low Birth Weight (LBW) neonates:
  • Medical stable neonates
  • Neonatal weight ≥2000g and <2500g
  • Born at Serrekunda Hospital
  • Gestational age will be >37 weeks.
  • Born to mothers at least 18 years of age
Show all 23Show fewer
  • Preterm neonates with Low Birth Weight (PTB+LBW):
  • Medical stable neonates
  • Born at Serrekunda Hospital
  • Neonates weighing <2500g and <37 weeks of gestational age.
  • Born to mothers at least 18 years of age
  • Preterm (PTB) neonates:
  • Medical stable neonates
  • >32 and <37 weeks' gestational age
  • Born at Serrekunda Hospital
  • PTB neonates will weigh more than 2500g
  • Born to mothers at least 18 years of age
  • Full Term (FT) neonates:
  • Healthy neonates
  • Born at Serrekunda Hospital
  • FT neonates will weigh ≥2500g
  • Gestational age ≥37 weeks
  • Born to mothers at least 18 years of age

Who cannot join

  • Major congenital malformations
  • Severe birth asphyxia
  • Children from multiple births
  • Medication (i.e. prophylactic antibiotics) given to neonate before first neonatal venous blood draw
  • Neonates born via Breech, Vacuum or C section
  • Neonates with infection/illness (information gained from venous bleed) will no longer be required to give future samples if originally required

Trial locations and contacts

1 site in 1 country.

The Gambia1 site
  • Serrekunda General Hospital

    Kanifing, Near Banjul

Other trials in The Gambia

About this study

Official title: Iron and Infection: Neonatal Nutritional Immunity (NeoInnate Study)

The motivation for this study was produced from our preliminary data, which showed that during the first 96 hours of life a full-term neonate will actively reduce the overall serum iron concentration of their blood and the transferrin saturation decreases rapidly from 45% in cord blood to ~20% by six hours post-delivery.

The Investigators hypothesise that this active sequestration of iron, which results in hypoferremia, is done in an effort to limit susceptibility to infection, a process referred to as nutritional immunity.

Read more

Currently, little is known about iron regulation and iron homeostasis during the first week of life and even less is known about the comparisons of nutritional immunity between full term, preterm and low birth weight neonates. Additionally, limited research has been conducted on the impact of these processes on bacterial pathogens.

In an effort to study the neonatal nutritional immunity and its role in neonatal susceptibility to infection, The investigator will conduct an observational study in full-term, preterm and low birth weight vaginally-delivered neonates born at Serrekunda General Hospital, The Gambia.

The investigators will fully characterise and quantify nutritional immunity during the early neonatal period and the investogators will assess how this impacts bacterial growth. Study sensitisation will occur at the antenatal clinic, during the mother's second trimester of pregnancy. Mothers will be consented and enrolled at delivery. Blood samples will be collected once from the umbilical cord and at serial time points from the neonates over the first week of life.

Read the detailed description

The epicentres of neonatal death worldwide are West and Central Africa, with an estimated 35 deaths per 1000 births. Neonatal infection is the third largest cause of death in children under five worldwide and is an ongoing major global public health challenge (WHO Millennium Development Goal 4). Intrauterine and neonatal infections have a high risk of causing substantial long-term neurological morbidity, affecting not just the individual but the local community and national productivity. Current research on neonatal sepsis in low-resource settings is focused on the use of mass perinatal antibiotic therapy for both mothers and babies. However, antibiotic resistance in the developing world is dramatically increasing and ablation of the neonatal microbiome has been linked with long-term health consequences. Novel therapeutic solutions are urgently required.

Nutritional immunity is the process by which the host innate immune system limits nutrient availability to invading organisms. Iron is an essential micronutrient for both microbial pathogens and their mammalian hosts. Changes in iron availability and distribution have significant effects on pathogen virulence and on the immune response to infection. Commonly found in blood, iron and its moieties (heme) are sequestered mainly in chaperone molecules (transferrin, lactoferrin, haptoglobin, hemopexin). The long-term goal of our research is to develop an anti-virulence therapeutic strategy that will augment nutritional immunity in the at-risk newborn, in order to improve neonatal survival, while avoiding the use of traditional empirical antibiotics.

During the dynamic neonatal period there are significant changes in circulation, oxygenation and iron homeostasis, the foetus maintains a high haematocrit to facilitate perfusion in utero. Within the first week of life, the neonate's haematocrit decreases as the RBCs containing foetal haemoglobin are broken down. Our preliminary data shows that during the first 24 hours of life full-term neonates will actively reduce the overall serum iron concentration and transferrin saturation decreases rapidly from 45% in cord blood to ~20% by six hours post-delivery.

Currently, little is known about nutritional immunity in the neonates or about its impact on bacterial pathogens. In the aims below, the investigators will investigate the hypothesis that nutritional immunity may be an evolutionary mechanism designed to protect neonates from infection during the first critical days of life, by limiting the pathogenicity and virulence of these organisms by reducing the availability of iron. The investigators hypothesize that this protective mechanism may not be activated in preterm and low birth weight neonates, putting these babies at an enhanced risk of neonatal infection.

Host chaperoned or unchaperoned iron, hemoglobin and heme in the blood can provide a growth-limiting nutrient to bacterial pathogens depending on the specific bacterial species and their iron-uptake mechanisms. Bacterial co-evolution with the host has resulted in two main strategies to combat host nutritional immunity: (1) chelation of iron away from chaperone proteins with siderophores, and (2) direct uptake of hemoglobin and heme moieties. Previous research and preliminary experiments conducted by our group, using ex-vivo growth assays in adult serum, has shown that growth of a panel of neonatal pathogenic bacteria each decreases in response to decreasing transferrin saturation and increases in response to increasing hemoglobin concentration. In addition, the investigators have shown that the in vitro growth of standard laboratory strains of four important causes of early neonatal sepsis in the developing world (Staphylococcus aureus, Klebsiella pneumoniae, Escherichia coli, and Streptococcus agalactiae) is decreased in hypoferremic serum collected from full term neonates between 6-24 hours after birth compared to serum from the umbilical cord at birth.

In an effort to study neonatal nutritional immunity and its role in neonatal susceptibility to infection, the investigators will conduct an observational study in full-term (FT), preterm (PTB) and low birth weight (LBW) vaginally-delivered neonates born at Serrekunda Hospital in The Gambia. The investigators will fully characterize and quantify nutritional immunity during the early neonatal period (Research Question 1, Research Question 2 and Research Question 3) and the investigators will assess how it impacts bacterial growth using in vitro assays (Research Question 4). Mothers will be consented and enrolled at delivery. Blood samples will be collected once from the umbilical cord and at serial time points from the neonates (see sampling schema).

Being tested
Observational study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Observational studyOther

    Observational study

Study groups in NCT03353051
Study groupRoleWhat they receive
Group A: other - observational studyneonates ≥2000-<2500g and born with a gestation age <37 weeks.
Receives: Other: Observational study
Group B: other- observational studyGroup B will contain neonates >2500g and born with a gestation age <37 weeks.
Receives: Other: Observational study
Group C: other - observational studyGroup C will contain neonates ≥2000-<2500g but with a gestation age >37 weeks.
Receives: Other: Observational study
Group D1:other - observational studyNeonate >2500g and born with a gestation age >37 weeks. These neonates will donate blood at 6-24hrs and at 30-48hrs.
Receives: Other: Observational study
Group D2: other - observational studyNeonate >2500g and born with a gestation age >37 weeks. These neonates will donate blood at 6-24hrs and at 42-60hrs
Receives: Other: Observational study
Group D3: other - observational studyNeonate >2500g and born with a gestation age >37 weeks. These neonates will donate blood at 6-24hrs and at 144-192hrs.
Receives: Other: Observational study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. serum iron

    will be measured using a COBAS INTEGRA 400 plus clinical chemistry analyzer

    Measured: at 7 days after birth

Secondary outcomes (3)
  1. TSAT (%) and heme iron (mg/dL)

    During the neonatal transition period in PTB and LBW neonates and FT babies in cord blood and at 6 hours after birth. TSAT and heme iron will be measured using a using a COBAS INTEGRA 400 plus clinical chemistry analyzer .

    Measured: at 6 hours after birth

  2. Iron (ug/dL), TSAT (%) and heme iron (mg/dL) regulated regulation in FT neonates

    During the first 7 days of life. Iron, TSAT and heme iron will be measured using a using a COBAS INTEGRA 400 plus clinical chemistry analyzer

    Measured: 7 days after birth

  3. microorganisms that are common causes of neonatal sepsis

    Does sera from PTB and LBW neonates after birth support more ex-vivo growth of microorganisms that are common causes of neonatal sepsis in Africa and The Gambia (Staphylococcus aureus, Klebsiella pneumoniae, Escherichia coli, Group B Streptococcus, Streptococcus pneumoniae and Salmonella Tyhpimurium) than sera from FT neonates

    Measured: At 0, 6 and 24 hours after birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2017
  2. Study start25 Jul 2017
  3. Primary completion21 Nov 2018
  4. Study completion3 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
430 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03353051
Sponsor's protocol ID
SCC1525
Acronym
NeoInnate
Status last verified
Feb 2020
First submitted
20 Jul 2017
Last updated
24 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cross JH, Jarjou O, Mohammed NI, Gomez SR, Touray BJB, Kessler NJ, Prentice AM, Cerami C. Iron homeostasis in full-term, normal birthweight Gambian neonates over the first week of life. Sci Rep. 2023 Jun 26;13(1):10349. doi: 10.1038/s41598-023-34592-z.

    PubMed 37365154
  • Cross JH, Jarjou O, Mohammed NI, Rayment Gomez S, Touray BJB, Prentice AM, Cerami C. Early postnatal hypoferremia in low birthweight and preterm babies: A prospective cohort study in hospital-delivered Gambian neonates. EBioMedicine. 2020 Feb;52:102613. doi: 10.1016/j.ebiom.2019.102613. Epub 2020 Jan 22.

    PubMed 31981986
  • Cross JH, Jarjou O, Mohammed NI, Prentice AM, Cerami C. Neonatal iron distribution and infection susceptibility in full term, preterm and low birthweight babies in urban Gambia: study protocol for an observational study. Gates Open Res. 2019 Oct 15;3:1469. doi: 10.12688/gatesopenres.12963.2. eCollection 2019.

    PubMed 31588425

Questions about this trial

What is this clinical trial studying?

An observational study of Neonatal Infection and Nutritional Anemia, run by London School of Hygiene and Tropical Medicine at 1 site in The Gambia.

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 23 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: finished, as of the sponsor's last update on 24 Feb 2020. 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 The Gambia. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

serum iron (time frame: at 7 days after birth). 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 NCT03353051, which also lists 3 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 24 Feb 2020.

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