Breastfeed a Better Youngster: the BABY Study (BABY)
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|ClinicalTrials.gov Identifier: NCT03674632|
Recruitment Status : Recruiting
First Posted : September 17, 2018
Last Update Posted : September 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breastfeeding Breastfeeding, Exclusive Infant Behavior Psychological Stress Breast Milk Expression Infant Development||Behavioral: Relaxation meditation tape||Not Applicable|
Participants will be recruited while they are in the maternity hospital. A baseline assessment will be conducted during the 1-week postpartum home visit, with another study visit at 8 weeks after delivery. After obtaining written informed consent, subjects will be randomly assigned to either the intervention arm or control conditions (standard management). Participants will be told that the aim of the study is to investigate factors that may make breastfeeding easier for mothers with a LPI and ETI, so they can breast-feed for longer. They will not be told about the randomisation until the end of the study, as this knowledge would most likely lead to mothers in the control group using some form of relaxation therapy. Background characteristics of mothers and their early feeding experiences will be recorded.
Participants can choose to complete the questionnaires on paper or online in their own time after the study visit. A breast milk sample will be collected pre-feed and infant anthropometry will be assessed by a trained nurse pre-feed at each home visit. Feed duration will be noted by the trained nurse. Stool samples of infants who were born vaginally will be collected by a trained nurse at baseline and at 8-weeks. At 3-month and 6-month postpartum, there will be a telephone contact to the participants for follow-up. Participants will be invited to complete the infant questionnaires again on paper or online in their own time.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Mother-infant Signalling During Lactation Following Late Preterm and Early Term Delivery: An Investigation of Physiological, Psychological and Anthropological Factors|
|Actual Study Start Date :||November 25, 2018|
|Estimated Primary Completion Date :||December 15, 2019|
|Estimated Study Completion Date :||January 15, 2020|
Experimental: relaxation meditation tape
Participants in this arm will be asked to use the relaxation therapy during the feed at least once a day. Participants will be given a diary to record when it is used. Participants will be encouraged to use the tape as often as they find it helpful.
Behavioral: Relaxation meditation tape
The tape used in this study is based on a meditation CD designed for breastfeeding mother (Menelli, 2004). The recording will be transcribed and translated into Chinese language by a certified yoga therapist.
No Intervention: Normal care
Participants in this arm will receive normal care from the Beijing Children Hospital
- Changes in maternal stress from baseline to 8 weeks postpartum [ Time Frame: 8 weeks ]Measurement for maternal stress will use the Cohen's Perceived Stress Scale (PSS). The PSS is a 14-item psychological self-rating scale for measuring the perception of stress on a scale of five, from 0 (never) to 4 (very often).
- Infant weight [ Time Frame: 8 weeks ]Infant weight will be measured at baseline and the 8-week home visit (unit kg)
- Infant length [ Time Frame: 8 weeks ]Infant length will be measured at baseline and the 8-week home visit (unit cm)
- Infant head circumference [ Time Frame: 8 weeks ]Infant head circumference will be measured at baseline and the 8-week home visit (unit cm)
- Infant temperament [ Time Frame: 8 weeks ]Measured using the revised Rothbart Infant Behaviour Questionnaire (RIBQ) at 2 months of age. The RIBQ is a 7-point Likert scale, from 1 (never) to 7 (always). Three major dimensions will be used for the assessment of infant temperament; surgency/extraversion, negative affectivity and orienting/regulation.
- Infant behaviour [ Time Frame: 8 weeks ]Measured by 3-day infant behaviour diary (average mins per day spent in each behavioural state). The diary consists of a time scale for 72 hours, which is divided into 15 minutes segments, and has five categories of behaviour: Sleeping, Awake and content, Fussy, Crying and Feeding.
- Infant appetite [ Time Frame: 8 weeks ]Measured using the Baby Eating Behaviour Questionnaire (BEBQ) at 2 months of age. It consists of 18 items designed to measure four traits: "enjoyment of food" (4 items), "food responsiveness" (5 items), "slowness in eating" (4 items), and satiety responsiveness" (5 items). The mothers in this study will be asked to rate all items based on a scale from 1 (never) to 5 (always).
- Composition of milk macronutrients (fat, protein, carbohydrate） [ Time Frame: 10 minutes ]Measured by Mid-infrared milk analyser (unit is g/100ml)
- Composition of microbiota in breastmilk samples at one week and 8-week postpartum [ Time Frame: 8 weeks ]Measured using the 16S rRNA based amplicon sequencing technique
- Composition of microbiota in stool samples at one week and 8-week postpartum [ Time Frame: 8 weeks ]Measured using the 16S rRNA based amplicon sequencing technique
- Breast milk volume at 8 weeks [ Time Frame: 8 weeks ]The milk volume will be measured using the test-weighing method.
- Energy content of the milk [ Time Frame: 10 minutes ]The energy content will estimated from the milk volume measurement provided by Mid-infrared milk analyser in ml and kcal/100ml
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): NCT03674632
|Contact: Zhuang Wei, PhD||+86 email@example.com|
|Beijing Children Hospital||Recruiting|
|Beijing, China, 100045|
|Contact: Zhuang Wei, PhD|
|Beijing, China, 100192|
|Contact: Zhuang Wei, PhD +86 13520312098 firstname.lastname@example.org|
|Principal Investigator:||Mary Fewtrell, PhD||University College, London|