Bronchopulmonary Dysplasia, Early-Onset Sepses, Neonatal, Enterocolitis, Necrotizing, Periventricular Haemorrhage Neonatal, Retinopathy of Prematurity, Small for Gestational Age Infant
Conditions
Brief 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. 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.
Interventions
DRUGZinc Sulfate
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.
DRUGPlacebos
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.
Sponsors
Fakultas Kedokteran Universitas Indonesia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
No minimum to 3 Days
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Weight | 8 to 12 weeks | Body weight measured by gram |
| Body Length | 8 to 12 weeks | Body length measured by centimetres |
| Head Circumference | 8 to 12 weeks | Head circumference measured by centimetres |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of mortality | 8 to 12 weeks | Comparison of mortality rates in participants with zinc supplementation and placebo |
| Number of participants with side effects | 8 to 12 weeks | Number of participants with side effects that occur due to zinc supplementation |
| Number of participants with bronchopulmonary dysplasia | 8 to 12 weeks | Comparison of number of participantswith bronchopulmonary dysplasia with zinc supplementation and placebo |
| Number of participants with intraventricular haemorrhage | 8 to 12 weeks | Comparison of number of participants with intraventricular haemorrhage with zinc supplementation and placebo |
| Number of participants with late-onset sepsis | 8 to 12 weeks | Comparison of number of participants with late-onset sepsis with zinc supplementation and placebo |
| Number of participants with retinopathy of prematurity | 8 to 12 weeks | Comparison of number of participantswith retinopathy of prematurity with zinc supplementation and placebo |
| Zinc levels | 8 to 12 weeks | Determine zinc levels before and after in participants with zinc supplementation and placebo |
Contacts
Primary ContactRisma Ke Kaban, Doctorate
Outcome results
None listed