Durham Anthropology Journal
Volume 16(1) 2009: 57-62. Copyright © 2009. Catherine Taylor
ISSN 1742-2930
Towards a Qualitative Follow-Up of a Randomised Trial on
the Post-Natal Ward
Catherine Taylor
Durham University
http://www.dur.ac.uk/anthropology.journal/vol16/iss1/taylor.pdf
Abstract
This paper provides a summary of a proposed PhD project that will be attached to a large randomised control
trial (RCT) designed to explore an intervention on the post-natal ward. The research will expand on the findings of the NECOT (North-East Cot) trial by adding a qualitative dimension. The main aims of the NECOT
trial are to examine the impact of different cot types used on the post-natal ward and their effect on breastfeeding duration. It is hypothesised that the use of side-car cribs will result in longer duration of breastfeeding than standard practice rooming-in. This project follows-up on the NECOT findings by examining the
impact of the intervention on mothers’ breastfeeding behaviour and infant sleep location once they have returned home. Additionally, the acceptability of side-car cribs among the post-natal ward staff will be assessed in order to identify factors that may increase or impede their future use within hospital maternity
wards.
Keywords
Breastfeeding, RCT (Randomised Control Trail), Post-natal, intervention, SIDS (Sudden Infant Death Syndrome)
Overview
The proposed project will be a qualitative investigation of at-home infant feeding and sleeping arrangements
among participants of a large, ongoing, randomised control trial (RCT). The NECOT (North-East Cot) trial
is an 1100 participant RCT examining an intervention in post-natal ward care designed to improve
breastfeeding duration. The proposed PhD project will augment this trial by adding an in-depth qualitative
research component to the current quantitative protocol. The NECOT Trial, funded by the NIHR Research
for the Patient Benefit Programme, is being conducted at the Royal Victoria Infirmary, Newcastle upon
Tyne, by Prof. H. Ball (anthropologist), Dr. M Ward Platt (paediatrician), J Gray (statistician), and Ms H.
Gray (midwifery sister). Recruitment for the NECOT trial commenced in January 2008.
Background
It is well documented that breastfeeding has numerous long and short-term benefits for both mother and
baby, which cannot be replicated via infant formula (see WHO 2008 for list of publications). The World
Health Organisation recommends that mothers should breastfeed their infants exclusively for six months and
continue to breastfeed alongside complimentary foods for two years or more (WHO 2002). Department of
Health statistics have revealed that few women in the UK achieve this goal and figures from the most recent
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Taylor 2009
Durham Anthropology Journal
Volume 16(1) 2009: 57-62. Copyright © 2009. Catherine Taylor
ISSN 1742-2930
Infant Feeding Survey conducted in 2005 show that of the prevalence of breastfeeding fell from 76% at birth
to 63% at one week, and to 48% at six weeks. At six months, only a quarter of mothers (25%) were still
breastfeeding. Furthermore, three-quarters (73%) of breastfeeding mothers who gave up within the survey
period said that they would have preferred to breastfeed for longer (Bolling et al 2005).
The initiation of breastfeeding is facilitated by skin-to-skin contact immediately after delivery and avoidance
of mother-baby separation, which has additional physiological and psychological benefits for both mother
and child (Christensson et al 1995; Fairbank et al 2000; Winberg 2005). A recent NICE review on effective
action for improving breastfeeding initiation and duration in the UK recommended that hospital practices
should ensure unrestricted mother-baby contact during the post-natal stay(Dyson et al 2006). However,
there has been little research conducted to assess ways of promoting close mother-baby contact in the postnatal period in relation to breastfeeding success and duration. A recent 2006 study by Ball et al observed the
effects of randomised infant sleep location on night time breastfeeding behaviour during the first two postnatal nights on the ward. This study found that babies who shared their mother’s bed or slept in a side-car
crib with unhindered opportunity to breastfeed showed greater breastfeeding effort, both in attempting to
feed and breastfeeding successfully, than babies who slept in stand-alone cots. Follow-up data from this
initial trial suggest that the increased breastfeeding effort observed on the post-natal ward has positive
implications for breastfeeding duration. Additionally, the study also showed that unhindered access for
mother and baby can be achieved safely through the use of side-car cribs for the duration of the post-natal
ward stay. These findings underpin the NECOT trial as they suggest that mothers who sleep in close physical
contact with their baby in the initial post-natal period have enhanced breastfeeding success with prolonged
breastfeeding duration and exclusivity.
The NECOT Trial
The NECOT trial is designed to test the hypothesis that the use of side-car cribs for babies on the post-natal
ward results in a longer duration of breastfeeding than standard practice rooming-in. The study design is a
RCT consisting of 1100 newly delivered mothers. Exclusion criteria for NECOT are: no prenatal intention
to breastfeed, multiple pregnancy, foetal abnormality, maternal illness following delivery and/or infant
admission to special care. Participants will take part in a telephone follow-up of breastfeeding behaviour on
a weekly basis for six months using an automated telephone key-pad data entry system developed and
piloted for the trial.
Qualitative Follow-up of the NECOT Trial: The follow-up research will augment the NECOT trial by
adding a qualitative dimension to the study. This will involve interviewing mothers and post-natal ward staff
involved in their care.
Qualitative Follow-up Rationale: Despite the known and potential benefits of using side-car cribs on the
post-natal ward, there are unanswered questions regarding subsequent infant sleep safety in the home
environment. An elevated risk of SIDS (sudden infant death syndrome) and fatal accidents involving infants
are associated with some forms of parent-infant sleep proximity, and the Department of Health discourages
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Durham Anthropology Journal
Volume 16(1) 2009: 57-62. Copyright © 2009. Catherine Taylor
ISSN 1742-2930
all sofa-sharing for infant sleep and direct bed-sharing infants less than three months (DoH 2007). This
potentially impacts the effectiveness of the intervention outside the confines of a trial since the intervention
may send out conflicting messages to mothers who may then engage in potentially dangerous sleep
behaviour once returning home. Although the NECOT trial will obtain prospective weekly data on infant
sleep location in the home, these important issues concerning infant sleep safety can only be fully explored
using a qualitative approach. Therefore appending this project to the NECOT trial will enhance the
interpretation of the quantitative findings and contribute to the feasibility of future side-car crib use and
health service delivery.
Main Objectives
1) assess the impact of the intervention on mothers’ breastfeeding experiences and behaviour after returning
home;
2) examine infant sleep location and assess the impact of the intervention on infant sleeping arrangements at
home;
3) explore mothers’ attitudes towards breastfeeding, co-sleeping, and night-time feeding;
4) investigate the acceptability of side-car cribs among post-natal ward staff and ascertain their willingness
to engage in the intervention outside of the context of the trial;
5) identify factors that may inhibit and improve side-car crib acceptability, widespread usage, and
promotion.
Methods
Maternal Interviews: 96 mothers will be interviewed; 48 from each randomised condition. Participants will
be recruited from the 800-900 newly delivered mothers who are anticipated to engage with follow-up for the
NECOT trial, therefore this qualitative project will involve 10-12% of the larger trial sample. Exclusion
criteria for NECOT are: no prenatal intention to breastfeed; multiple pregnancy; foetal abnormality;
maternal illness following delivery; infant admission to special care. Purposive sampling will be employed
to select 96 mothers from within this pool of participants in order to generate an interview sample reflecting
a diversity of backgrounds in order to maximise the potential range of views captured. Interview selection
variables will be maternal age (<25; >=25 years); parity (0, 1+); delivery type (vaginal, surgical) according
to the following grid:
Randomised
condition
Age group
Parity group
Vaginal delivery
DAJ 16/1
Side-car
<25 years
Rooming-in
25+ years
<25 years
25+years
Parity= 0 Parity=1+ Parity=0 Parity=1+ Parity=0 Parity=1+ Parity=0 Parity=1+
6
6
6
6
6
6
6
6
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Taylor 2009
Durham Anthropology Journal
Volume 16(1) 2009: 57-62. Copyright © 2009. Catherine Taylor
ISSN 1742-2930
Surgical delivery
6
6
6
6
6
6
6
6
Therefore from each arm of the NECOT trial six mothers will be interviewed from each cell of the
recruitment grid. This will permit comparison of behaviours and attitudes of mothers belonging to different
age groups and parity, and with different delivery experiences, in relation to breastfeeding and sleep
environment outcomes. Each variable is selected as having a significant impact on breastfeeding initiation
and duration in the UK (Bolling et al 2005; Hamlyn et al 2000). Maternal interviews will be conducted faceto-face at two months postpartum in either the participants’ homes or at their local health visitor clinic.
Those who are breastfeeding at two months will be contacted for a follow-up telephone interview at four
months and again at six months, if breastfeeding was ongoing at four months, in order to develop a
longitudinal picture of breastfeeding experience and infant sleep environments. Approximately ~50% of
participants are anticipated to be breastfeeding at four months and ~25% at six months, therefore 70-80
follow-up telephone interviews are predicted.
Staff Interviews: A purposive sample of 8-12 post-natal ward staff involved in or affected by the delivery of
the intervention will be interviewed towards the completion of the NECOT trial. The sampling strategy will
encompass all grades of post-natal ward staff from day and night shifts, plus managers. Face-to-face
interviews will be scheduled at a convenient time and suitable location within the hospital. Staff interviews
will focus on acceptability and perceived impact of the side-car crib intervention, difficulties and benefits
encountered, and reflections on staff attitudes to the trial and the potential for change in post-natal wards
procedures.
Transcription and Analyses: For all face-to-face interviews, a semi-structured interview technique will be
employed since this method allows the interview to remain open-ended while following an interview guide
in order to gain detailed information about the proposed topics (Bernard 2001). This method also allows the
participants to volunteer additional information they feel to be relevant, which serves to enhance the quality
of the data collected. For transcription purposes, all face-to-face interviews with mothers and staff will be
digitally recorded with the participants’ permission. For telephone follow-up interviews, handwritten notes
will be made on a pre-formatted interview schedule. Interview transcripts will be subjected to qualitative
thematic analysis. This will involve identifying patterns and themes within the data and interpreting findings
objectively from both an etic and emic perspective to ensure validity (Bernard 2001). Qualitative software
tools (e.g. NVIVO) will be employed in this process. The sample size will also permit extraction of some
quantifiable data from the interviews which will be coded and analysed in conjunction with numerical
follow-up data extracted from the main NECOT trial database.
Ethical Considerations
An extension to NHS ethics approval will be sought for the NECOT study in order to encompass this
proposal. Ethical concerns for this project will be guided by the recommendations laid out by the ASA
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Durham Anthropology Journal
Volume 16(1) 2009: 57-62. Copyright © 2009. Catherine Taylor
ISSN 1742-2930
(1999) and will involve informed consent, confidentiality, and anonymity for interviews with both mothers
and staff, and recognition that mothers participating in the NECOT trial should not be overburdened with
research requests. Prospective participants will be provided with written and verbal information about this
additional project and consent will be obtained. Participants will be advised that interviews will be recorded
and confidentiality and anonymity will be assured, except where legal obligations exist i.e. child neglect/
abuse. During interviews, undue intrusion into the participants’ privacy will be avoided and research will be
conducted in a respectable manner. Participants will be informed that they may withdraw from the
investigation at any stage during the study without affecting their involvement in the NECOT trial or their
NHS care.
Value to Public Health, Medical and Social Sciences
Increasing the duration of breastfeeding is an important public health activity. In addition to protecting
mothers and infants from a variety of health problems (relating to infant, childhood and lifetime health)
breastfeeding is cost effective for both the government and individuals. In the UK, millions of pounds are
spent treating childhood illnesses that may be avoided by exclusively breastfeeding for the recommended
period of six months (NICE 2006). It was estimated in 1995 that the NHS spends £35million per year
treating gastroenteritis in formula-fed infants and that for each 1% increase in breastfeeding at 13 weeks, a
saving of £500,000 in the treatment of gastroenteritis would be achieved (DoH 1995). Many women who
choose to breastfeed face unexpected difficulties in the initial post-natal period, which leads to early
curtailment of breastfeeding. The NECOT trial hypothesizes that side-car cribs will extend breastfeeding
duration and exclusivity by facilitating breastfeeding in the post-natal period which is essential for
stimulating milk production and establishing effective long-term breastfeeding practices. However, issues
relating to infant safety and acceptability of the intervention need to be addressed before side-car cribs can
be brought into general use, which requires qualitative, in-depth investigation. A medical anthropological
perspective recognises that breastfeeding and sleep proximity are both biomedical and socio-cultural issues.
Therefore, this project will be focused on uncovering the impact of the intervention on behaviours and
attitudes and in identifying the factors that may enhance or impede future use of side-car cribs in post-natal
wards. A key strength of this investigation is that it considers the effect of the intervention from both a
patient and a health professional viewpoint, which serves to provide a broader understanding of the issues
under examination.
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Practice.’ ASA Website (http://www.asa.anthropology.ac.uk/ethics2.html). Accessed on 11.8.06.
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ISSN 1742-2930
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