Comparison of Breastfeeding Teaching Intervention
BFTS
Comparison of Teaching Interventions to Improve Breastfeeding Among Mothers of Infants In Neonatal Intensive Care Unit of Brookdale Hospital Medical Center
1 other identifier
interventional
100
1 country
1
Brief Summary
Investigators plan to include mother-infant couplets admitted to Neonatal Intensive Care Unit(NICU) at Brookdale Hospital for clinical reasons during one year period 1/2018-1/2019. Participants whose infants have health conditions that will not allow breastfeeding, not able to read or understand English and/or participants refusing to provide phone numbers, an email address or mail address for future communication will not be included in the study. After obtaining an informed consent, participants will be allocated to one of the four study groups by randomization and participants will receive either no education or one of the verbal/written/video education at two different time points: within 4 days and at 2 weeks from the time of birth of the infant. Participants whose infants are in NICU and are feeding expressed breastmilk will be instructed to bring all the expressed breastmilk to NICU and to keep records of the date, time and the amount of expressed breastmilk in the log book maintained at the bedside of the infant. Participants who are directly feeding the infant on breast will be contacted by third personnel who is blind to which study group the participant belongs to qualitatively evaluate breast feeding in terms of frequency, duration, exclusive breast feeding at 2 weeks, 4 weeks and 6 weeks from the time of birth. Participants will be requested not to reveal the study team about the mode of teaching method she has received when she is contacted at 2 weeks, 4 weeks and 6 weeks for the evaluation of the breast feeding. Investigators will also go through the medical records of participants and their infants to collect some demographic data and clinical characteristics pertinent for the study such as age, parity, weight of the infant. Thus, investigators plan to compare the breast-feeding outcome quantitatively among participants who are feeding expressed breast milk and qualitatively as duration/exclusive breast-feeding among participants who are feeding directly on breast following three different teaching interventions: written or verbal or video and find out the most effective method of teaching intervention
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2019
Shorter than P25 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
May 30, 2018
CompletedFirst Posted
Study publicly available on registry
July 27, 2018
CompletedStudy Start
First participant enrolled
February 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedJanuary 18, 2019
January 1, 2019
10 months
May 30, 2018
January 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (12)
amount of breast milk expression
amount of breast milk expression in milliliters
2 weeks
Duration of breast feeding
Duration of breast feeding in weeks
2 weeks
Frequency of breast feeding
Frequency of breast feeding in number of times in a day
2 weeks
Exclusive breast feeding
Exclusive breast feeding as yes or no
2 weeks
amount of breast milk expression
amount of breast milk expression in milliliters
4 weeks
amount of breast milk expression
amount of breast milk expression in milliliters
6 weeks
Duration of breast feeding
Duration of breast feeding in weeks
4 weeks
Duration of breast feeding
Duration of breast feeding in weeks
6 weeks
Frequency of breast feeding
Frequency of breast feeding in number of times in a day
4 weeks
Frequency of breast feeding
Frequency of breast feeding in number of times in a day
6 weeks
Exclusive breast feeding
Exclusive breast feeding as yes or no
4 weeks
Exclusive breast feeding
Exclusive breast feeding as yes or no
6 weeks
Study Arms (4)
Group 1
NO INTERVENTIONNo study related education given
Group 2
EXPERIMENTALWritten BF education
Group 3
EXPERIMENTALVerbal BF education
Group 4
EXPERIMENTALVideo BF education
Interventions
Breastfeeding education in three different forms: written/verbal/video
Eligibility Criteria
You may qualify if:
- Mother-infant couplets with newborns admitted to NICU at Brookdale Hospital for clinical reasons.
You may not qualify if:
- Any contraindications to breast-feeding such as galactosemia, protein milk allergy, HIV infection, maternal substance abuse
- Mothers not able to read and/or understand English
- Mothers refusing to provide phone number or an email address or mail address for future communication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brookdale University hospital and Medical Center
Brooklyn, New York, 11212, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Surichhya Bajracharya
Brookdale University Hospital Medical Center
- STUDY DIRECTOR
Sravanti Kurada
Brookdale University Hospital Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident in pediatrics
Study Record Dates
First Submitted
May 30, 2018
First Posted
July 27, 2018
Study Start
February 1, 2019
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
January 18, 2019
Record last verified: 2019-01