NCT04285437

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2020

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 26, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

February 26, 2020

Status Verified

February 1, 2020

Enrollment Period

10 months

First QC Date

February 19, 2020

Last Update Submit

February 24, 2020

Conditions

Infant DevelopmentBreastfeedingPostnatal Depression

Keywords

infant massage

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (7)

  • The mean of Edinburgh Postnatal Depression Scale

    at the day baby turns 1 month of age

  • The mean of Edinburgh Postnatal Depression Scale

    at the day baby turns 2 month of age

  • Change of the number of defecation times at 2 month - old - infant

    2 months after birth

  • Change of the number of spitting up at 2 month - old - infant

    2 months after birth

  • Change of weight at 2 month - old - infant

    2 months after birth

  • +2 more secondary outcomes

Study Arms (2)

massage

EXPERIMENTAL

neonates are massaged by their mother during the first 2 months after birth.

Behavioral: infant massage

control

NO INTERVENTION

neonates are not massaged.

Interventions

infant massageBEHAVIORAL

Mother will be trained how to massage their babies by International Association of Infant Massage (IAIM) Certified Infant Massage Instructor, and then their babies will be massaged by themselves during the first 2 months after birth.

massage

Eligibility Criteria

Age1 Day - 15 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Medicine and Pharmacy

Ho Chi Minh City, 70000, Vietnam

RECRUITING

MeSH Terms

Conditions

Breast FeedingDepression, Postpartum

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorPuerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Study Officials

  • Tuan Le Minh, Ph.D, MD

    Research Department, UMP

    STUDY CHAIR

Central Study Contacts

Linh Dao Nguyen Phuong, MD

CONTACT

+84902893839bs.dnplinh@gmail.com

Duong Pham Diep Thuy, Ph.D, MD

CONTACT

+84908143227thuyduongpd@ump.edu.vn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 19, 2020

First Posted

February 26, 2020

Study Start

January 31, 2020

Primary Completion

December 1, 2020

Study Completion

December 30, 2020

Last Updated

February 26, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

VN(1)