Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 13 of 562 for:    Recruiting, Not yet recruiting, Available Studies | Teaching

Comparison of Breastfeeding Teaching Intervention (BFTS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03602729
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Surichhya Bajracharya, Brookdale University Hospital Medical Center

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


Condition or disease Intervention/treatment Phase
Breast Feeding Other: Breastfeeding education Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Comparison of Teaching Interventions to Improve Breastfeeding Among Mothers of Infants In Neonatal Intensive Care Unit of Brookdale Hospital Medical Center
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Group 1
No study related education given
Experimental: Group 2
Written BF education
Other: Breastfeeding education
Breastfeeding education in three different forms: written/verbal/video

Experimental: Group 3
Verbal BF education
Other: Breastfeeding education
Breastfeeding education in three different forms: written/verbal/video

Experimental: Group 4
Video BF education
Other: Breastfeeding education
Breastfeeding education in three different forms: written/verbal/video




Primary Outcome Measures :
  1. amount of breast milk expression [ Time Frame: 2 weeks ]
    amount of breast milk expression in milliliters

  2. Duration of breast feeding [ Time Frame: 2 weeks ]
    Duration of breast feeding in weeks

  3. Frequency of breast feeding [ Time Frame: 2 weeks ]
    Frequency of breast feeding in number of times in a day

  4. Exclusive breast feeding [ Time Frame: 2 weeks ]
    Exclusive breast feeding as yes or no

  5. amount of breast milk expression [ Time Frame: 4 weeks ]
    amount of breast milk expression in milliliters

  6. amount of breast milk expression [ Time Frame: 6 weeks ]
    amount of breast milk expression in milliliters

  7. Duration of breast feeding [ Time Frame: 4 weeks ]
    Duration of breast feeding in weeks

  8. Duration of breast feeding [ Time Frame: 6 weeks ]
    Duration of breast feeding in weeks

  9. Frequency of breast feeding [ Time Frame: 4 weeks ]
    Frequency of breast feeding in number of times in a day

  10. Frequency of breast feeding [ Time Frame: 6 weeks ]
    Frequency of breast feeding in number of times in a day

  11. Exclusive breast feeding [ Time Frame: 4 weeks ]
    Exclusive breast feeding as yes or no

  12. Exclusive breast feeding [ Time Frame: 6 weeks ]
    Exclusive breast feeding as yes or no



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mother-infant couplets with newborns admitted to NICU at Brookdale Hospital for clinical reasons.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03602729


Contacts
Layout table for location contacts
Contact: Surichhya Bajracharya 7184907210 suribajracharya@gmail.com
Contact: Sravanti Kurada 5739154820 sravy83@gmail.com

Locations
Layout table for location information
United States, New York
Brookdale University hospital and Medical Center Recruiting
Brooklyn, New York, United States, 11212
Contact: Surichhya Bajracharya, MD    718-490-7210    suribajracharya@gmail.com   
Contact: Mary Augustian, MD    9293915578    Maugusti@bhmcny.org   
Principal Investigator: Mary Augustian, MD         
Sponsors and Collaborators
Brookdale University Hospital Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Surichhya Bajracharya Brookdale University Hospital Medical Center
Study Director: Sravanti Kurada Brookdale University Hospital Medical Center

Layout table for additonal information
Responsible Party: Surichhya Bajracharya, Resident in pediatrics, Brookdale University Hospital Medical Center
ClinicalTrials.gov Identifier: NCT03602729     History of Changes
Other Study ID Numbers: 18-02
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Surichhya Bajracharya, Brookdale University Hospital Medical Center:
Breastfeeding
Teaching
Intervention
NICU