Comparison of Breastfeeding Teaching Intervention
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | Any |
| Updated: | 1/20/2019 |
| Start Date: | February 2019 |
| End Date: | December 2019 |
| Contact: | Surichhya Bajracharya |
| Email: | suribajracharya@gmail.com |
| Phone: | 7184907210 |
Comparison of Teaching Interventions to Improve Breastfeeding Among Mothers of Infants In Neonatal Intensive Care Unit of Brookdale Hospital Medical Center
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
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
The purpose of the study is to compare the breast-feeding outcome following three different
teaching interventions: written or verbal/direct or visual/videos among participants whose
infants are admitted in Neonatal Intensive Care Unit (NICU) at Brookdale Hospital
1. Breast-feeding outcome among participants who are feeding expressed breast milk will be
measured quantitatively as amount of milk production per day on an average during NICU
stay.
2. Breast-feeding outcome among participants who are directly feeding the infants at breast
will be measured qualitatively in terms of frequency, duration, exclusive breast feeding
at 2 weeks, 4 weeks and 6 weeks of infant's life.
CLINICAL SIGNIFICANCE Investigators are including participants whose infants are admitted to
the Brookdale NICU This also include very preterm [<32 weeks] infants, the period when
breastfeeding incidence has been lesser compared to participants who give birth at later
gestation and those who don't require admission to NICU. By including participants who give
birth <32 weeks and newborns admitted to NICU, investigators will be able to document the
quantity of breast milk production by logging the milk brought to our NICU storage freezer by
participants and effectively measure the outcome objectively of the three different
interventions [written, verbal and visual methods].
Previous studies have found that breast feeding is lower among African American population.
Since most of population at Brookdale hospital is African American, this study will also give
an opportunity to find the result of education intervention among this population
Investigators propose that this study will be useful to find the most effective mode to
educate participants whose neonates admitted to NICU about breast-feeding and may enhance the
culture of breastmilk feeding in this population and therefore increase breast feeding among
newborns admitted to the NICU.
METHODOLOGY This is a prospective randomized study on breast-feeding teaching intervention on
participants who give birth to newborns that are admitted to NICU at Brookdale Hospital
during one-year period 1/2018-1/2019.
All participants who deliver at Brookdale hospital receive regular breast-feeding education
on benefit of exclusive breastfeeding, latching, pumping provided by the nurses or physicians
during postpartum period while they are admitted in the hospital. The participants also
receive education on breastfeeding through public health assistant/volunteer through New York
City (NYC) Family and Child Health Bureau of Maternal Infant and Reproductive Health either
at the hospital and or during home visit following discharge.
Any education provided as a part of research is the additional education participant will
receive on top of the regular education all participants receive irrespective of their
participation and the group they belong to in the study. Participant decision to participate
or not in the study will not affect the regular health care and education participant or
participant's infant will receive in the hospital.
The aim of the study is to obtain at-least 25 participants per group for a total sample size
of 100 participants and 100 participants' infants.
Once investigators identify the participants fulfilling the inclusion criteria, one of the
two trained investigators will take an informed consent that include permission to contact
participants over the phone or by email/mail at 2 weeks, 4 weeks and 6 weeks for providing
the appropriate method of teaching intervention and/ or measurement of breast feeding
outcome.
Randomization will be done by picking up one of the random numbers representing each group
such as 1 for Group 1, 2 for Group 2, 3 for Group 3 and 4 for Group 4:
Group 1: Participants in this group will not receive additional teaching interventions
included in the research. Participants will be contacted at 2 weeks, 4 weeks and 6 weeks
postpartum to evaluate amount, duration, exclusive breast feeding.
Group 2: Participants in this group will receive the written breast-feeding education in the
form of booklet (included with this protocol). Booklet will be distributed 2 times: 1st time
in the hospital within 4 days of birth of the infant before the participant is discharged and
at 2 weeks from the time of birth of the infant utilizing the time when participant visits to
the NICU. If the participant is not able to visit NICU or the infant is discharged from the
hospital before 2 weeks from the time of birth, booklet will be provided to the participant
by post or as an attachment in an email. Participants will be contacted at 2 weeks, 4 weeks
and 6 weeks postpartum to evaluate amount, duration, exclusive breast feeding Group 3:
Participants in this group will receive breast-feeding education verbally (please find the
content of verbal education in following page). Verbal education will be provided 2 times:
1st time in the hospital within 4 days of birth of the infant before the participant is
discharged. Subsequent breast-feeding trouble shooting verbal education will be provided at 2
weeks from the time of birth of the infant utilizing the time when participant visits to the
NICU. If the participant is not able to visit NICU or the infant is discharged from the
hospital before 2 weeks from the time of birth, verbal education will be provided to the
participant over the phone. Participants will be contacted at 2 weeks, 4 weeks and 6 weeks
postpartum to evaluate amount, duration, exclusive breast feeding Group 4: Participants in
this group will receive breast-feeding education through the video format. (links for the
video is provided in the following page). Video education will be provided 2 times: 1st time
in the hospital within 4 days of birth of the infant before the participant is discharged.
Subsequent breast-feeding video education will be provided at 2 weeks from the time of birth
of the infant by sending a link for the video in participant's email. Participants will be
contacted at 2 weeks, 4 weeks and 6 weeks postpartum to evaluate amount, duration, exclusive
breast feeding All three forms of education will include similar information that include
advantages of breast-feeding, optimization of pumping using hand pump or electric pump,
storage of milk and such other troubleshooting during breastfeeding
Written education method:
Written education will be provided in the form of booklet. Investigators have received 100
booklets 'your guide to breastfeeding' from The U.S. Department of Health and Human Services
Office on Women's Health (OWH) for free. Investigators will provide the booklet to the
participants that belong to group 2 as written education within 4 days of the birth of the
infant and at 2 weeks from the time of birth of the infant.
This standard booklet can be found free at the government website below:
https://www.womenshealth.gov/files/documents/your-guide-to-breastfeeding.pdf
Verbal education method:
Verbal education will be provided by one of the two investigators who will use the checklist
to provide the information. Both investigators have successfully completed online "Supporting
and Promoting Breastfeeding in Health Care Settings modules' from School of Public Health,
University of Albany, State University of New York. Both investigators will be trained by a
neonatologist so that the verbal education method provided by two different investigators is
similar. The checklist in verbal education is derived from the above standard booklet so that
the information provided is same as the booklet.
Video education method:
There is standard you-tube video link for free at the following government website:
https://www.womenshealth.gov/printables-and-shareables/resource/videos Participants will be
provided you-tube video links included in the following table within 4 days and at 2 weeks
from the time of birth of the infant.
teaching interventions: written or verbal/direct or visual/videos among participants whose
infants are admitted in Neonatal Intensive Care Unit (NICU) at Brookdale Hospital
1. Breast-feeding outcome among participants who are feeding expressed breast milk will be
measured quantitatively as amount of milk production per day on an average during NICU
stay.
2. Breast-feeding outcome among participants who are directly feeding the infants at breast
will be measured qualitatively in terms of frequency, duration, exclusive breast feeding
at 2 weeks, 4 weeks and 6 weeks of infant's life.
CLINICAL SIGNIFICANCE Investigators are including participants whose infants are admitted to
the Brookdale NICU This also include very preterm [<32 weeks] infants, the period when
breastfeeding incidence has been lesser compared to participants who give birth at later
gestation and those who don't require admission to NICU. By including participants who give
birth <32 weeks and newborns admitted to NICU, investigators will be able to document the
quantity of breast milk production by logging the milk brought to our NICU storage freezer by
participants and effectively measure the outcome objectively of the three different
interventions [written, verbal and visual methods].
Previous studies have found that breast feeding is lower among African American population.
Since most of population at Brookdale hospital is African American, this study will also give
an opportunity to find the result of education intervention among this population
Investigators propose that this study will be useful to find the most effective mode to
educate participants whose neonates admitted to NICU about breast-feeding and may enhance the
culture of breastmilk feeding in this population and therefore increase breast feeding among
newborns admitted to the NICU.
METHODOLOGY This is a prospective randomized study on breast-feeding teaching intervention on
participants who give birth to newborns that are admitted to NICU at Brookdale Hospital
during one-year period 1/2018-1/2019.
All participants who deliver at Brookdale hospital receive regular breast-feeding education
on benefit of exclusive breastfeeding, latching, pumping provided by the nurses or physicians
during postpartum period while they are admitted in the hospital. The participants also
receive education on breastfeeding through public health assistant/volunteer through New York
City (NYC) Family and Child Health Bureau of Maternal Infant and Reproductive Health either
at the hospital and or during home visit following discharge.
Any education provided as a part of research is the additional education participant will
receive on top of the regular education all participants receive irrespective of their
participation and the group they belong to in the study. Participant decision to participate
or not in the study will not affect the regular health care and education participant or
participant's infant will receive in the hospital.
The aim of the study is to obtain at-least 25 participants per group for a total sample size
of 100 participants and 100 participants' infants.
Once investigators identify the participants fulfilling the inclusion criteria, one of the
two trained investigators will take an informed consent that include permission to contact
participants over the phone or by email/mail at 2 weeks, 4 weeks and 6 weeks for providing
the appropriate method of teaching intervention and/ or measurement of breast feeding
outcome.
Randomization will be done by picking up one of the random numbers representing each group
such as 1 for Group 1, 2 for Group 2, 3 for Group 3 and 4 for Group 4:
Group 1: Participants in this group will not receive additional teaching interventions
included in the research. Participants will be contacted at 2 weeks, 4 weeks and 6 weeks
postpartum to evaluate amount, duration, exclusive breast feeding.
Group 2: Participants in this group will receive the written breast-feeding education in the
form of booklet (included with this protocol). Booklet will be distributed 2 times: 1st time
in the hospital within 4 days of birth of the infant before the participant is discharged and
at 2 weeks from the time of birth of the infant utilizing the time when participant visits to
the NICU. If the participant is not able to visit NICU or the infant is discharged from the
hospital before 2 weeks from the time of birth, booklet will be provided to the participant
by post or as an attachment in an email. Participants will be contacted at 2 weeks, 4 weeks
and 6 weeks postpartum to evaluate amount, duration, exclusive breast feeding Group 3:
Participants in this group will receive breast-feeding education verbally (please find the
content of verbal education in following page). Verbal education will be provided 2 times:
1st time in the hospital within 4 days of birth of the infant before the participant is
discharged. Subsequent breast-feeding trouble shooting verbal education will be provided at 2
weeks from the time of birth of the infant utilizing the time when participant visits to the
NICU. If the participant is not able to visit NICU or the infant is discharged from the
hospital before 2 weeks from the time of birth, verbal education will be provided to the
participant over the phone. Participants will be contacted at 2 weeks, 4 weeks and 6 weeks
postpartum to evaluate amount, duration, exclusive breast feeding Group 4: Participants in
this group will receive breast-feeding education through the video format. (links for the
video is provided in the following page). Video education will be provided 2 times: 1st time
in the hospital within 4 days of birth of the infant before the participant is discharged.
Subsequent breast-feeding video education will be provided at 2 weeks from the time of birth
of the infant by sending a link for the video in participant's email. Participants will be
contacted at 2 weeks, 4 weeks and 6 weeks postpartum to evaluate amount, duration, exclusive
breast feeding All three forms of education will include similar information that include
advantages of breast-feeding, optimization of pumping using hand pump or electric pump,
storage of milk and such other troubleshooting during breastfeeding
Written education method:
Written education will be provided in the form of booklet. Investigators have received 100
booklets 'your guide to breastfeeding' from The U.S. Department of Health and Human Services
Office on Women's Health (OWH) for free. Investigators will provide the booklet to the
participants that belong to group 2 as written education within 4 days of the birth of the
infant and at 2 weeks from the time of birth of the infant.
This standard booklet can be found free at the government website below:
https://www.womenshealth.gov/files/documents/your-guide-to-breastfeeding.pdf
Verbal education method:
Verbal education will be provided by one of the two investigators who will use the checklist
to provide the information. Both investigators have successfully completed online "Supporting
and Promoting Breastfeeding in Health Care Settings modules' from School of Public Health,
University of Albany, State University of New York. Both investigators will be trained by a
neonatologist so that the verbal education method provided by two different investigators is
similar. The checklist in verbal education is derived from the above standard booklet so that
the information provided is same as the booklet.
Video education method:
There is standard you-tube video link for free at the following government website:
https://www.womenshealth.gov/printables-and-shareables/resource/videos Participants will be
provided you-tube video links included in the following table within 4 days and at 2 weeks
from the time of birth of the infant.
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
We found this trial at
1
site
Brooklyn, New York 11212
Principal Investigator: Mary Augustian, MD
Phone: 718-490-7210
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