| Revision date | Field name | Previous value |
|---|---|---|
| September 11, 2017 | Expected recruitment end date | 2017-09-06 |
| September 11, 2017 | Centre name 1 | Boo Ali Hospital |
| September 11, 2017 | Center / Contact details 1 / Address | Boo Ali Hospital, Pasdaran Blv, Imam Squ, Sari, Mazandaran, Iran |
| September 11, 2017 | summary | The present study aimes to assess the therapeutic effect of the researcher-made cotoneaster drop on jaundice in infants undergoing phototherapy. The study population consists of all infants with jaundice. The present randomized double-blind clinical trial is conducted on four groups of infants; Group 1: The infant with jaundice and the mother receive placebo. Group 2: The infant with jaundice and the mother receive cotoneaster drops. Group 3: The infant with jaundice receives cotoneaster drops and the mother receives placebo. Group 4: The infant with jaundice receives placebo and the mother receives cotoneaster drops. The sample size is determined using mean difference formula as 50 infants in each group, making a total sample size of 200 infants. Conduct and randomization: Cotoneaster and placebo drops (medication and placebo) are produced by Sobhan Pharmaceutical Company in similar bottles and packing. A computer software program is used to produce random numbers to allocate the medication and placebo to four groups. Adequate medication and placebo for each group (for both infants and mothers) will be placed in a special envelope marked with patient number and medication code. Thus, patients, doctor and assessor will have no knowledge of the nature of medication or group allocation. Infants and mothers will enter the present study according to inclusion criteria and receive their particular medications. The study setting will be in Bu Alisina Hospital in Sari. Inclusion criteria include all breastfed infants weighing between 2500 and 4000 grams and present with jaundice. Exclusion criteria include having incompatible blood group (RH), suffering from fauvism, being preterm, needing blood transfusion, suffering from infection or being the case of hemolysis |
| May 8, 2017 | Expected recruitment end date | 2017-03-05 |
| May 8, 2017 | summary | The present study aimes to assess the therapeutic effect of the researcher-made cotoneaster drop on jaundice in infants undergoing phototherapy. The study population consists of all infants with jaundice. The present randomized double-blind clinical trial is conducted on four groups of infants; Group 1: The infant with jaundice and the mother receive placebo. Group 2: The infant with jaundice and the mother receive cotoneaster drops. Group 3: The infant with jaundice receives cotoneaster drops and the mother receives placebo. Group 4: The infant with jaundice receives placebo and the mother receives cotoneaster drops. The sample size is determined using mean difference formula as 50 infants in each group, making a total sample size of 200 infants. Conduct and randomization: Cotoneaster and placebo drops (medication and placebo) are produced by Sobhan Pharmaceutical Company in similar bottles and packing. A computer software program is used to produce random numbers to allocate the medication and placebo to four groups. Adequate medication and placebo for each group (for both infants and mothers) will be placed in a special envelope marked with patient number and medication code. Thus, patients, doctor and assessor will have no knowledge of the nature of medication or group allocation. Infants and mothers will enter the present study according to inclusion criteria and receive their particular medications. The study setting will be in Bu Alisina Hospital in Sari. Inclusion criteria include all breastfed infants weighing between 2500 and 4000 grams and present with jaundice. Exclusion criteria include being twins, having incompatible blood group (RH), suffering from fauvism, being preterm, needing blood transfusion, suffering from infection or being the case of hemolysis. |
| June 18, 2017 | Primary outcome measure 2 | The frequency of defecation |
| June 11, 2017 | Expected recruitment end date | 2017-07-06 |
| June 11, 2017 | Inclusion / Exclusion | Inclusion criteria: All infants who present with jaundice, whose weights are 2500 to 4000 gr and who are feeding with breast milk.<br /> Exclusion criteria twin babies; blood incompatibility; Rh incompatibility; Fauvism; immaturity; need for blood transfusions; infection; hemolysis.<br /> |
| June 11, 2017 | Minimum age | 0 |
| June 11, 2017 | Maximum age | 0 |
| June 11, 2017 | Trial phase | N/A |