Early-Onset Sepses, NeonatalPhase 4NCT04050488
Zinc Supplementation on Very Low Birth Weight Infant
A Phase 4 study testing Zinc Sulfate in people with Early-Onset Sepses, Neonatal and Periventricular Haemorrhage Neonatal, run by Fakultas Kedokteran Universitas Indonesia.
Trial summary
Premature birth is a major cause of neonatal death in addition to neonatal asphyxia and infections. Early in life, premature babies must get aggressive nutrition so that there is no extrauterine growth restriction (EUGR) in the Intrauterine Growth Restriction (IUGR) group compared to the non-IUGR group. Read more about this study
- Who is it for?
- Ages Up to 3 daysHealthy volunteers can take part
- Conditions the study is for
- Early-Onset Sepses, Neonatal, Periventricular Haemorrhage Neonatal, Bronchopulmonary Dysplasia
- What is being tested?
- Zinc Sulfate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 364 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2019to 31 Jul 2020
- Phase
- Phase 4
- 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 Up to 3 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preterm (gestational age of 28 - 32 weeks)
- Newborns with a ratio of body weight and gestational age: Small for Gestational Age or Large for Gestational Age
- Get parental approval to be included in the study by signing an informed consent
Who cannot join
- Newborns with severe congenital abnormalities
- Newborns with digestive tract abnormalities: partial, total obstruction or gastrointestinal atresia
- Newborns with unstable hemodynamic conditions that will affect the survival rate
- Mothers who consume alcohol regularly (≧ 2x a month) during pregnancy
- Newborns with early-onset sepsis
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Oral Zinc Supplementation Improving Growth and Reducing Morbidity on Very Low Birth Weight Infant
Premature birth is a major cause of neonatal death in addition to neonatal asphyxia and infections.
Early in life, premature babies must get aggressive nutrition so that there is no extrauterine growth restriction (EUGR) in the Intrauterine Growth Restriction (IUGR) group compared to the non-IUGR group.
Read more
Other factors that also play a role are long episodes of fasting, the fulfillment of nutrition (macro and micronutrients) from the start, time to start breastfeeding (ASI), duration of parenteral total administration, the incidence of respiratory distress syndrome and incidence of necrotizing enterocolitis.
Zinc is one of the micronutrients which is very risky for deficiency in premature babies.
Babies with zinc deficiency experience growth disorders as much as 67%. In India, infants who received zinc supplementation increased after being given 10 days of zinc supplementation and lower mortality rates in the group with supplementation. Very low birth weight babies and bronchopulmonary dysplasia who received zinc supplementation during the week showed good clinical progress and the growth rate also increased.
The investigators believe this study has the potential for decreasing infant mortality from its current level and can be a growth indicator for preterm babies.
Read the detailed description
Double-blind randomized controlled clinical trial in preterm infants (28 - 32 weeks) who are newborn or less than 3 days old who are admitted to the perinatology room.
Infant in the intervention group was given elemental zinc supplementation once daily orally compared to placebo in the control group, at 3 days of age until the patient returned home or a maximum of 40 weeks' gestation.
The intervention group was given 10 mg elemental zinc once daily orally compared to placebo in the control group, at 3 days of age and received oral nutrition> 20cc / kg/ day, continued during treatment until the patient returned home or a maximum of 40 weeks' gestation.
Monitored infant development indicators, measured once a week. Monitoring of the incidence of infection in late-onset infants in clinical and laboratory settings according to the existing hospital settings.
The monitoring of NEC events in all research subjects was carried out. Screening ROP at the age of 3 weeks and/or when the baby is going home. The participants were observed to be allowed to go home or a maximum of 40 weeks' gestation if they were still being treated.
- Conditions
- Early-Onset Sepses, Neonatal, Periventricular Haemorrhage Neonatal, Bronchopulmonary Dysplasia, Retinopathy of Prematurity, Enterocolitis, Necrotizing, Small for Gestational Age Infant
- Being tested
- Zinc Sulfate, Placebos
- Medical subject headings
- Neonatal Sepsis, Bronchopulmonary Dysplasia, Retinopathy of Prematurity, Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc SulfateDrug
At the age of 3 days or priming> 20cc / kg body weight/day the research assistant will give a bottle of medicine containing zinc (according to the results of randomization) without knowing the contents either by the doctor or the room nurse.
PlacebosDrug
At the age of 3 days or priming> 20cc / kg body weight/day the research assistant will give a bottle of medicine containing placebo (according to the results of randomization) without knowing the contents either by the doctor or the room nurse.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Active comparator | Participants who receive the intervention. Receives: Drug: Zinc Sulfate |
| Control Group | Placebo comparator | Participants who receive the placebo. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
Body weight measured by gram
Measured: 8 to 12 weeks
Body Length
Body length measured by centimetres
Measured: 8 to 12 weeks
Head Circumference
Head circumference measured by centimetres
Measured: 8 to 12 weeks
Secondary outcomes (7)
Zinc levels
Determine zinc levels before and after in participants with zinc supplementation and placebo
Measured: 8 to 12 weeks
Rate of mortality
Comparison of mortality rates in participants with zinc supplementation and placebo
Measured: 8 to 12 weeks
Number of participants with side effects
Number of participants with side effects that occur due to zinc supplementation
Measured: 8 to 12 weeks
Number of participants with late-onset sepsis
Comparison of number of participants with late-onset sepsis with zinc supplementation and placebo
Measured: 8 to 12 weeks
Number of participants with intraventricular haemorrhage
Comparison of number of participants with intraventricular haemorrhage with zinc supplementation and placebo
Measured: 8 to 12 weeks
Number of participants with bronchopulmonary dysplasia
Comparison of number of participantswith bronchopulmonary dysplasia with zinc supplementation and placebo
Measured: 8 to 12 weeks
Number of participants with retinopathy of prematurity
Comparison of number of participantswith retinopathy of prematurity with zinc supplementation and placebo
Measured: 8 to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start20 Aug 2019 (estimated)
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Jul 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 Early-Onset Sepses, NeonatalStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind randomized controlled clinical trial in preterm infants (28 - 32 weeks) who are newborn or less than 3 days old who are admitted to the perinatology room. There were two research groups, namely the treatment group (the group that received zinc supplementation) and the control group (the group that received the placebo). In both groups the differences in growth indicators (body weight, body length, and head circumference) will be evaluated, the incidence of morbidity (sepsis, necrotizing enterocolitis, retinopathy of prematurity, intraventricular hemorrhage and bronchopulmonary dysplasia).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 364 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fakultas Kedokteran Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RismaKK, Fakultas Kedokteran Universitas Indonesia
- Investigators
- Henri Azis, Master, Principal investigator, Fakultas Kedokteran Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04050488
- Sponsor's protocol ID
- IKA001
- Status last verified
- Aug 2019
- First submitted
- 30 Jul 2019
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This research can be done in other places by considering the condition of existing medical servants. When giving a good outcome, you can contact the research contact
Publications
Terrin G, Berni Canani R, Passariello A, Messina F, Conti MG, Caoci S, Smaldore A, Bertino E, De Curtis M. Zinc supplementation reduces morbidity and mortality in very-low-birth-weight preterm neonates: a hospital-based randomized, placebo-controlled trial in an industrialized country. Am J Clin Nutr. 2013 Dec;98(6):1468-74. doi: 10.3945/ajcn.112.054478. Epub 2013 Sep 11.
PubMed 24025633Banupriya N, Bhat BV, Benet BD, Catherine C, Sridhar MG, Parija SC. Short Term Oral Zinc Supplementation among Babies with Neonatal Sepsis for Reducing Mortality and Improving Outcome - A Double-Blind Randomized Controlled Trial. Indian J Pediatr. 2018 Jan;85(1):5-9. doi: 10.1007/s12098-017-2444-8. Epub 2017 Sep 11.
PubMed 28891027
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Zinc Supplementation Improving Growth and Reducing Morbidity on Very Low Birth Weight Infant
- ClinicalTrials.gov ID
- NCT04050488
- Acronym / sponsor ID
- IKA001
- Conditions
- Early-Onset Sepses, Neonatal, Periventricular Haemorrhage Neonatal, Bronchopulmonary Dysplasia, Retinopathy of Prematurity, Enterocolitis, Necrotizing, Small for Gestational Age Infant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 364 participants (estimated)
- Lead sponsor
- Fakultas Kedokteran Universitas IndonesiaUniversity, hospital or other
- Study start
- 20 Aug 2019 (estimated)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 8 Aug 2019 (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.
Premature birth is a major cause of neonatal death in addition to neonatal asphyxia and infections.
Early in life, premature babies must get aggressive nutrition so that there is no extrauterine growth restriction (EUGR) in the Intrauterine Growth Restriction (IUGR) group compared to the non-IUGR group.
Other factors that also play a role are long episodes of fasting, the fulfillment of nutrition (macro and micronutrients) from the start, time to start breastfeeding (ASI), duration of parenteral total administration, the incidence of respiratory distress syndrome and incidence of necrotizing enterocolitis.
Zinc is one of the micronutrients which is very risky for deficiency in premature babies.
Babies with zinc deficiency experience growth disorders as much as 67%. In India, infants who received zinc supplementation increased after being given 10 days of zinc supplementation and lower mortality rates in the group with supplementation. Very low birth weight babies and bronchopulmonary dysplasia who received zinc supplementation during the week showed good clinical progress and the growth rate also increased.
The investigators believe this study has the potential for decreasing infant mortality from its current level and can be a growth indicator for preterm babies.
Detailed description
Double-blind randomized controlled clinical trial in preterm infants (28 - 32 weeks) who are newborn or less than 3 days old who are admitted to the perinatology room.
Infant in the intervention group was given elemental zinc supplementation once daily orally compared to placebo in the control group, at 3 days of age until the patient returned home or a maximum of 40 weeks' gestation.
The intervention group was given 10 mg elemental zinc once daily orally compared to placebo in the control group, at 3 days of age and received oral nutrition> 20cc / kg/ day, continued during treatment until the patient returned home or a maximum of 40 weeks' gestation.
Monitored infant development indicators, measured once a week. Monitoring of the incidence of infection in late-onset infants in clinical and laboratory settings according to the existing hospital settings.
The monitoring of NEC events in all research subjects was carried out. Screening ROP at the age of 3 weeks and/or when the baby is going home. The participants were observed to be allowed to go home or a maximum of 40 weeks' gestation if they were still being treated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind randomized controlled clinical trial in preterm infants (28 - 32 weeks) who are newborn or less than 3 days old who are admitted to the perinatology room. There were two research groups, namely the treatment group (the group that received zinc supplementation) and the control group (the group that received the placebo). In both groups the differences in growth indicators (body weight, body length, and head circumference) will be evaluated, the incidence of morbidity (sepsis, necrotizing enterocolitis, retinopathy of prematurity, intraventricular hemorrhage and bronchopulmonary dysplasia).
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Active comparator | Drug: Zinc SulfateParticipants who receive the intervention. |
| Control Group | Placebo comparator | Drug: PlacebosParticipants who receive the placebo. |
Who may qualify
- Ages
- Up to 3 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Preterm (gestational age of 28 - 32 weeks)
- Newborns with a ratio of body weight and gestational age: Small for Gestational Age or Large for Gestational Age
- Get parental approval to be included in the study by signing an informed consent
Key exclusion criteria (5 listed)
- Newborns with severe congenital abnormalities
- Newborns with digestive tract abnormalities: partial, total obstruction or gastrointestinal atresia
- Newborns with unstable hemodynamic conditions that will affect the survival rate
- Mothers who consume alcohol regularly (≧ 2x a month) during pregnancy
- Newborns with early-onset sepsis
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 |
|---|---|---|
| Zinc SulfateAt the age of 3 days or priming> 20cc / kg body weight/day the research assistant will give a bottle of medicine containing zinc (according to the results of randomization) without knowing the contents either by the doctor or the room nurse. | Drug | Treatment Group |
| PlacebosAt the age of 3 days or priming> 20cc / kg body weight/day the research assistant will give a bottle of medicine containing placebo (according to the results of randomization) without knowing the contents either by the doctor or the room nurse. | Drug | Control Group |
Primary outcome
Body Weight
Time frame: 8 to 12 weeks
Body weight measured by gram
Body Length
Time frame: 8 to 12 weeks
Body length measured by centimetres
Head Circumference
Time frame: 8 to 12 weeks
Head circumference measured by centimetres
7 secondary outcomes
Zinc levels
Time frame: 8 to 12 weeks
Rate of mortality
Time frame: 8 to 12 weeks
Number of participants with side effects
Time frame: 8 to 12 weeks
Number of participants with late-onset sepsis
Time frame: 8 to 12 weeks
Number of participants with intraventricular haemorrhage
Time frame: 8 to 12 weeks
Number of participants with bronchopulmonary dysplasia
Time frame: 8 to 12 weeks
Number of participants with retinopathy of prematurity
Time frame: 8 to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
- Background: PubMed 24025633Terrin G, Berni Canani R, Passariello A, Messina F, Conti MG, Caoci S, Smaldore A, Bertino E, De Curtis M. Zinc supplementation reduces morbidity and mortality in very-low-birth-weight preterm neonates: a hospital-based randomized, placebo-controlled trial in an industrialized country. Am J Clin Nutr. 2013 Dec;98(6):1468-74. doi: 10.3945/ajcn.112.054478. Epub 2013 Sep 11.
- Background: PubMed 28891027Banupriya N, Bhat BV, Benet BD, Catherine C, Sridhar MG, Parija SC. Short Term Oral Zinc Supplementation among Babies with Neonatal Sepsis for Reducing Mortality and Improving Outcome - A Double-Blind Randomized Controlled Trial. Indian J Pediatr. 2018 Jan;85(1):5-9. doi: 10.1007/s12098-017-2444-8. Epub 2017 Sep 11.
- Individual participant dataSharing planned: No. This research can be done in other places by considering the condition of existing medical servants. When giving a good outcome, you can contact the research contact
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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.
Henri Azis, Master principal investigator
Fakultas Kedokteran Universitas Indonesia
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zinc Sulfate in people with Early-Onset Sepses, Neonatal and Periventricular Haemorrhage Neonatal, run by Fakultas Kedokteran Universitas Indonesia.
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 3 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: status not confirmed, as of the sponsor's last update on 15 Aug 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Risma Ke Kaban, Doctorate (+62 816 902 051, rismakk@yahoo.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight (time frame: 8 to 12 weeks). The study lists 3 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 NCT04050488, 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 15 Aug 2019.