| Revision date | Field name | Previous value |
|---|---|---|
| September 11, 2017 | Secondary outcome timepoint 2 | Added at 2017-06-18: Every 24 hours for 5 days |
| September 11, 2017 | Primary outcome time point 1 | Added at 2017-06-11: Every 24 hours for 5 days |
| September 11, 2017 | summary | <br /> نام انگلیسی فیلد<br /> The study is a randomized double-blind clinical trial. The purpose of this study is the investigating of prophylactic effect of Manna of Cotoneaster in management of neonatal hyperbilirubinemia. This study was performed on 400 infant\'s patients, who admitted into neonatal ward in Imam Khomeini hospital, Sari, Iran. Informed consent will be obtained from mothers. Inclusion criteria: All newborns are examined by doctor who not with jaundice and weight is between 2.5 to 4 kg. Exclusion criteria: Babies with a genetic anomaly, Congenital, Intrauterine infection or jaundice within 24 hours of birth and mothers who are not satisfied and want to be excluded. Randomization: using blocking method. Groups: in intervention group, Manna of Cotoneaster as oral drops will be given to the neonate 6 hours after birth. In the control group placebo will be administered concurrently with intervention group. The Blind: To double-blind study, Manna of cotoneaster solution and placebo solution container similar appearance and the user, administer and appraiser of them do not know about it. After administration of Manna of Cotoneaster, all neonates are examined by neonatal specialist. Dose of Manna of cotoneaster, which is the daily 3 times to about 1 gram of oral drops, will be given to the baby. The bilirubin concentration measured in 3 sets (24 hours 48 hours and 72 hours after birth) and its number is recorded. The Meconium departure time controlled daily for three days after birth. The baby bilirubin concentration measured through the skin by bilirubin test device. Then on the third day that neonatal thyroid screening test will be done, bilirubin concentration measured through the skin with the same device. |
| September 11, 2017 | Expected recruitment end date | 2017-09-06 |
| May 24, 2017 | Expected recruitment end date | 2017-02-03 |
| June 18, 2017 | Secondary outcome timepoint 1 | Daily for three days |
| June 18, 2017 | summary | The study is a randomized double-blind clinical trial. The purpose of this study is the investigating of prophylactic effect of Cotoneaster in management of neonatal hyperbilirubinemia. This study was performed on 400 infant\'s patients, who admitted into neonatal ward in Imam Khomeini hospital, Sari, Iran. Informed consent will be obtained from mothers. Inclusion criteria: All newborns are examined by doctor who not with jaundice and weight is between 2.5 to 4 kg. Exclusion criteria: Babies with a genetic anomaly, Congenital, Intrauterine infection or jaundice within 24 hours of birth and mothers who are not satisfied and want to be excluded. Randomization: using blocking method. Groups: in intervention group, Cotoneaster as oral drops will be given to the neonate 6 hours after birth. In the control group placebo will be administered concurrently with intervention group. The Blind: To double-blind study, cotoneaster solution and placebo solution container similar appearance and the user, administer and appraiser of them do not know about it. After administration of Cotoneaster, all neonates are examined by neonatal specialist. Dose of cotoneaster, which is the daily 3 times to about 1 gram of oral drops, will be given to the baby. The bilirubin concentration measured in 3 sets (24 hours 48 hours and 72 hours after birth) and its number is recorded. The Meconium departure time controlled daily for three days after birth. The baby bilirubin concentration measured through the skin by bilirubin test device. Then on the third day that neonatal thyroid screening test will be done, bilirubin concentration measured through the skin with the same device. |
| June 18, 2017 | Scientific title | The investigating of prophylactic effect of Cotoneaster in management of neonatal hyperbilirubinemia |
| June 18, 2017 | Scientific title | The investigating of prophylactic effect of Cotoneaster in management of neonatal hyperbilirubinemia |
| June 18, 2017 | Public title | The investigating of prophylactic effect of Cotoneaster in management of neonatal hyperbilirubinemia |
| June 18, 2017 | Primary outcome measure 2 | Added at 2017-06-11: The frequency of defecation |
| June 18, 2017 | Secondary outcome timepoint 1 | Daily for three days |
| June 18, 2017 | Secondary outcome timepoint 1 | Daily for three days |
| June 18, 2017 | Secondary outcome 1 | Bilirubin amount |
| June 11, 2017 | Primary outcome method of measurement 1 | Observe and record |
| June 11, 2017 | Primary outcome time point 1 | Daily for three days |
| June 11, 2017 | Trial phase | 2-3 |
| June 11, 2017 | Minimum age | 0 |
| February 7, 2017 | Expected recruitment start date | 2016-10-06 |