Breastfeeding Clinical Trial
Official title:
The Effects of Massage Therapy on Mental and Physical Development of Term Neonates and on Maternal Bonding.
This study collects data from 2 groups of mother- term neonate pairs at the Neonatal Department of Children Hospital II, Ho Chi Minh City (in group M: neonates are massaged by their mothers during the first 2 months after birth, in group X: neonates are not massaged), and then, evaluates the effects of Massage Therapy on the mental and physical development of neonates and on maternal bonding (breast feeding, postnatal depression) during the first 2 months after birth.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | December 30, 2020 |
Est. primary completion date | December 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 15 Days |
Eligibility |
Inclusion Criteria: Group of mother and neonate at Neonatal Department of Children Hospital
II, Ho Chi Minh City - neonate: full term, not low birth weight, 0 - 15 days of age, diagnosed with one of the following conditions and has been treated stably: uncomplicated neonatal infection, uncomplicated pneumonia, non umbilical cord infection, uncomplicated neonatal jaundice - mother: live in Ho Chi Minh City Exclusion Criteria: If the mother or neonate has the criteria to eliminate: - Mother with mental illness, developmental disorder, prenatal depression, not directly caring for children. - Neonate with multiple deformities, asphyxia, severe jaundice with complication, cow's milk allergy, heart/ lung/central nervous system defects. |
Country | Name | City | State |
---|---|---|---|
Vietnam | University of Medicine and Pharmacy | Ho Chi Minh City |
Lead Sponsor | Collaborator |
---|---|
Ho Chi Minh City University of Medicine and Pharmacy |
Vietnam,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The rate of pairs that have Edinburgh Postnatal Depression Scale scored > 12 | When home visiting, the investigator let the mother do Edinburgh Postnatal Depression Scale | at the day baby turns 1 month of age | |
Primary | The rate of pairs that have Edinburgh Postnatal Depression Scale scored > 12 | When home visiting, the investigator let the mother do Edinburgh Postnatal Depression Scale | at the day baby turns 2 month of age | |
Primary | Change of the number of crying times over 15 minutes at 2 month - old - infant | When home visiting, the investigator collect from "Parenting Dairy" | 2 months after birth | |
Primary | The rate of pairs that have breastfeeding | When home visiting, the investigator collect from "Parenting Dairy" | at the day baby turns 1 month of age | |
Primary | The rate of pairs that have breastfeeding | When home visiting, the investigator collect from "Parenting Dairy" | at the day baby turns 2 month of age | |
Secondary | The mean of Edinburgh Postnatal Depression Scale | When home visiting, the investigator let the mother do Edinburgh Postnatal Depression Scale | at the day baby turns 1 month of age | |
Secondary | The mean of Edinburgh Postnatal Depression Scale | When home visiting, the investigator let the mother do Edinburgh Postnatal Depression Scale | at the day baby turns 2 month of age | |
Secondary | Change of the number of defecation times at 2 month - old - infant | When home visiting, the investigator collect from "Parenting Dairy" | 2 months after birth | |
Secondary | Change of the number of spitting up at 2 month - old - infant | When home visiting, the investigator collect from "Parenting Dairy" | 2 months after birth | |
Secondary | Change of weight at 2 month - old - infant | When home visiting, the investigator assess the weight of infant | 2 months after birth | |
Secondary | Change of height at 2 month - old - infant | When home visiting, the investigator assess the height of infant | 2 months after birth | |
Secondary | Change of head circle at 2 month - old - infant | When home visiting, the investigator assess the head circle of infant | 2 months after birth |
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