Recruiting

Breastfeeding Intervention

Sponsor:

Brookdale University Hospital Medical Center

Code:

NCT03602729

Conditions

Breast Feeding

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Breastfeeding education

Study Details

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

Conditions

Breast Feeding

Study ID

NCT03602729

Start date

Feb, 2019

Status verified date

Jan, 2019

Completion date

Dec, 2019

Anticipated

Primary completion date

Dec, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

no intervention: Group 1

No study related education given

experimental: Group 2

Written BF education

experimental: Group 3

Verbal BF education

experimental: Group 4

Video BF education

Interventions

Breastfeeding education

Breastfeeding education in three different forms: written/verbal/video

Primary outcome measure

  • amount of breast milk expression [ Time Frame: 2 weeks ]
  • Duration of breast feeding [ Time Frame: 2 weeks ]
  • Frequency of breast feeding [ Time Frame: 2 weeks ]
  • Exclusive breast feeding [ Time Frame: 2 weeks ]
  • amount of breast milk expression [ Time Frame: 4 weeks ]
  • amount of breast milk expression [ Time Frame: 6 weeks ]
  • Duration of breast feeding [ Time Frame: 4 weeks ]
  • Duration of breast feeding [ Time Frame: 6 weeks ]
  • Frequency of breast feeding [ Time Frame: 4 weeks ]
  • Frequency of breast feeding [ Time Frame: 6 weeks ]
  • Exclusive breast feeding [ Time Frame: 4 weeks ]
  • Exclusive breast feeding [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Locations

Brookdale University hospital and Medical Center

Recruiting

Brooklyn, New York, United States, 11212

Contacts

Principal Investigator:

Mary Augustian, MD

More Information

Sponsor

Brookdale University Hospital Medical Center

Last update posted

Jan 18, 2019

Last verified

Jan, 2019

Keywords

  • Breastfeeding
  • Teaching
  • Intervention
  • NICU

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brookdale University Hospital Medical Center on 2019-01-18.