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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Active Comparator | Participants who receive the intervention. |
|
| Control Group | Placebo Comparator | Participants who receive the placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zinc Sulfate | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight | Body weight measured by gram | 8 to 12 weeks |
| Body Length | Body length measured by centimetres | 8 to 12 weeks |
| Head Circumference | Head circumference measured by centimetres | 8 to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Zinc levels | Determine zinc levels before and after in participants with zinc supplementation and placebo | 8 to 12 weeks |
| Rate of mortality | Comparison of mortality rates in participants with zinc supplementation and placebo |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Risma Ke Kaban, Doctorate | Contact | +62 816 902 051 | rismakk@yahoo.co.uk |
| Name | Affiliation | Role |
|---|---|---|
| Henri Azis, Master | Fakultas Kedokteran Universitas Indonesia | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24025633 | Background | 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. | |
| 28891027 |
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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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| ID | Term |
|---|---|
| D000071074 | Neonatal Sepsis |
| D001997 | Bronchopulmonary Dysplasia |
| D012178 | Retinopathy of Prematurity |
| D020345 | Enterocolitis, Necrotizing |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D019287 | Zinc Sulfate |
| ID | Term |
|---|---|
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
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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).
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Randomization is carried out by research assistants, then making sequential numbers with closed envelopes that have been prepared. The results of the randomization are only known by research assistants. At the age of 3 days or priming> 20cc / kg body weight/day, the research assistant will give a bottle of medicine containing zinc/placebo (according to the results of randomization) without knowing the contents either by the doctor or the room nurse. The researcher monitors all patients who are sampled without knowing which group is the test and which group is the control.
| Placebos | Drug | 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. |
|
| 8 to 12 weeks |
| Number of participants with side effects | Number of participants with side effects that occur due to zinc supplementation | 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 | 8 to 12 weeks |
| Number of participants with intraventricular haemorrhage | Comparison of number of participants with intraventricular haemorrhage with zinc supplementation and placebo | 8 to 12 weeks |
| Number of participants with bronchopulmonary dysplasia | Comparison of number of participantswith bronchopulmonary dysplasia with zinc supplementation and placebo | 8 to 12 weeks |
| Number of participants with retinopathy of prematurity | Comparison of number of participantswith retinopathy of prematurity with zinc supplementation and placebo | 8 to 12 weeks |
| Background |
| Banupriya 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. |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007235 | Infant, Premature, Diseases |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D007287 |
| Inorganic Chemicals |
| D017967 | Zinc Compounds |