Formulation and theoretical perspectives. Effect of the first two hours after birth skin-to-skin contact for full term infants on first breastfeeding experience and breastfeeding duration: A randomised controlled trial
It is unquestioned that breastfeeding is the most significant form of providing nutrition for infants. Exclusive breastfeeding for at least the first six month of life, with continued breastfeeding for up to two years or longer is highly recommended by World Health Organization (World Health Organization, 2000). In addition, The American Academy of Paediatrics (1997) stats "Exclusive breastfeeding is ideal nutrition and sufficient to support optimal growth and development for the first six months after birthâ€¦It is recommended that breastfeeding continue for at least twelve months, and thereafter for as long as mutually desired". According to The American Academy of Paediatrics (1997) described the benefits of breastfeeding including improved general health, growth, and development of the breastfed infant; decreased incidence and severity of diarrhoea, lower respiratory infections, ear infections, bacterial meningitis, botulism, and urinary tract infections; protection from sudden infant death syndrome, childhood cancer, insulin dependent diabetes mellitus, Crohn's disease, ulcerative colitis, allergies, and other chronic digestive diseases; and enhanced cognitive development.
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To compare with other Europe countries, breastfeeding rates in the UK are low (UNICEF, 1999). In 2005, 45% of all mothers in the United Kingdom were breastfeeding exclusively at one week, while 21% were feeding exclusively at six weeks. At six months the proportion of mothers who were breastfeeding exclusively was negligible (<1%) (Infant Feeding Survey 2005, 2007).
The Baby Friendly Initiative was introduced in the UK in 1992 by the WHO and UNICEF. The purpose of the programme is to encourage hospitals to increase protection, promotion and support breastfeeding and implement the Ten Steps to Successful Breastfeeding (UNICEF 1998). Step four recommends skin-to-skin contact (SSC) in the early postnatal period, which should last until the first feed or for as long as the mother wishes (UNICEF, 1998).
The process of skin-to-skin contact was defined as "the infant is naked in a prone position and skin-to-skin on the mother's bare abdomen or chest during the first minute postbirth. Apgar scores are assigned and suctioning is done if medically indicated. The infant must be gently dried and covered across the back with a prewarmed blanket. The initial physical assessment is performed while the infant is with the mother skin-to-skin. To prevent heat loss, the infant's head must be covered with a dry cap, which is replaced when it becomes damp. Ideally, all other interventions are delayed until at least after the end of the first breastfeeding" (Moore & Anderson, 2007).
The optimal time for newborn babies to develop pre-breastfeeding behaviour, such as rooting and sucking (Gomez, et al., 1998), skin-to-skin contact and provide first breastfeeding is the first two hours postbirth when they are more alert to the environment. In this stage, it may indicate a "sensitive period" for establish effective breastfeeding. Bornstein (1989) defines sensitive period as "a developmental phase of built-in competence for the development of specific behaviour exchanges between the organism and the environment whose consequences presumably endure for the organism." After this sensitive period, the two hours postbirth, many newborn babies go into a drowsy stage which maybe difficult to arouse for up to several hours (Britton, 1998).
Purpose of the research
Previous studies found that infants were eight times more likely to breastfeed spontaneously if they spent more than 50 minutes in skin-to-skin contact with their mothers immediately after birth, and concluded that the dose of skin-to-skin contact might be a critical component regarding breastfeeding success (Gomez. et al., 1998). Despite numerous documents and randomized control trials have showed the positive impact of skin-to-skin contact on breastfeeding, mother-infant separation by physical assessment and routine care during the first hours postbirth before having the opportunity to start skin-to-skin contact and breastfeeding is still common practice in many healthcare settings.
In light of the above, the aim of the study is to examine the effects of skin-to-skin contact for full-term newborn babies during the first two hours postbirth on first breastfeeding experience and exclusive breastfeeding rate in six months postbirth. Two hypotheses will be tested: (1) skin-to-skin contact during the first two hours postbirth has positive impact on first breastfeeding experience; (2) skin-to-skin contact during the first two hours postbirth increases the likelihood of breastfeeding establishment; (3) skin-to-skin contact during the first two hours postbirth increases both breastfeeding establishment and duration.
2. Methods to be used
The topic was "skin-to-skin contact and breastfeeding rate" and the methodology selected was quantitative. This is because breastfeeding rate is to be measured precisely so as to allow comparisons between the various groups. And for relative representativeness and for generalisations made quantitative research a better choice.
The study will be conducted by randomised controlled trial comparing the effects of SSC with routine care on first breastfeeding experience and breastfeeding duration.
In the control group which receiving routine care, babies will quickly dried and wrapped in a towel before being handed to their mother or father. Mother-baby contact will be interrupted for physical assessment, given a vitamin K injection, weighing, dressing and measuring the baby, or for repairing the mother's perineum wound. After the routine care finish, the baby will be swaddled in prewarmed blankets and return to the mother. And the staff nurse will assist with breast feeding when both mother and baby are ready. In the skin-to-skin care group, the infants will be given to their mothers immediately after birth and will be placed nakedly in a prone position against the mother's skin between the breasts with a large pre-warmed blanket. After the cord cut, the infant will be moved to radiant warmer for the same routine care as the control group then back to their mother again for about 2 hours. And when both mother and baby in skin-to-skin group are ready, the staff nurse also will assist with breast feeding.
2.1 Sampling principles and procedures
Criteria for including/excluding study participants
Eligible participants included pregnant woman who are primiparas mothers, had no pre-existing medical complications and no history of mental illness or illicit drug use, 18 years or older, expecting a vaginal delivery, intended to breast feed, her healthy fetus need to greater than 37 weeks' gestation. A woman will be ineligible if their babies weighted less than 2200gm, < 37 weeks' gestation, have a 5-minutes Apgar score < 7 or have medical complications at birth that against skin-to-skin contact or mothers who require either skin-to-skin contact or no skin-to-skin contact after delivery, or had a multiple pregnancy.
In Shiau's study (1997), skin-to-skin contact dyads had better breastfeeding status than control dyads on day 28 (6.16 ± 2.06 vs. 4.0 ± 1.60, P= .004). This computes to an effect size of 1.17. And in Moore's study (2007), the author used the data to compute power in her study for the samples were similar in their research. Moore(2007) indicated if the true effect size is 1.17, the probability of detecting significant differences between the two groups is 81% (i.e., 19% of the time significant differences would not be detected). Therefore, 10 participants per group may be adequate to detect statistically significant between-group differences in breastfeeding status and Moore also used minimization to control the influence of the variables, she explained that in small studies, simple randomization procedures are
likely to result in groups that are unbalanced with respect to potentially confounding variables.
For the above reason, in this research, a sample of 10 participants per group will be appropriate but to avoid possible attrition during the time, 15 participants will be recruited.
The participants will be recruited through a hospital in Manchester with the help of clinical nurse and maternity consultants. Women who fulfill the inclusion criteria will be contacted by the clinical coordinator at 36-37 week's gestation. The women will provided with oral explanation about the trial, eligible participants will be recruited
and informed consent will be obtained. After birth, mothers and their newborn babies who still remained eligible will be randomized using minimization to either skin-to-skin group or control group.
2.2 Data collection methods
Minimization is an assignment strategy, similar in intention to stratification that ensures excellent balance between intervention groups for specified prognostic factors. The next participant is assigned to whichever group would minimize the imbalance between groups on specified prognostic factors. Minimization is an acceptable alternative to random assignment (CONSORT, 2007). The minimization program will be applied to control the following variables: baby gender, birth weight, and gestational age, maternal age, education, marital status, race, smoking history, breastfeeding intention and maternal employment (no, part-time, or full-time employment).
When participants admit to the hospital in active labour, the clinical co-ordinator will be contacted for information gathering. And when all the information obtained, the computerized minimization programme will assign randomly either to skin-to-skin group or control group. Demographic, labour and delivery history data (past and current pregnancies) from the records will be collected by the clinical co-ordinator. Post-delivery data collection will be carried out through contact with the mothers before they left hospital.
Post-delivery care will be observed by the research assistant as well as assessment of first breastfeeding in the delivery room. The infant's first breastfeeding will be score by the research assistant by using the IBFAT. The IBFAT measures 4 aspect of suckling competence: (1) infant state of arousal or readiness to feed; (2) rooting reflex; (3) latch-on; and (4) suckling pattern. Each item has a score of 0 to 3 for a maximum score of 12, indicating "competent" breastfeeding. Success of the first breastfeeding (score of 10 to 12) will be measured by this tool. The IBS, which assesses the degree of breastfeeding exclusivity; The IBS is a single-item indicator consisting of three major levels of breastfeeding: full, partial, and token. Eight levels are ranked from 1 for exclusive to 8 for weaned. Full is divided into two subcategories: exclusive (the infant consumes only breast milk and no other liquid or solid food [score=1]), and almost exclusive (the infant is given water, juice, vitamins, and minerals infrequently in addition to breast milk [score= 2]). The partial category, which originally had two subcategories, was subdivided into four subcategories for greater accuracy: high-partial (> 80% of the infant's diet is breast milk [score= 3]); medium-high (50% - 80% breast milk[score = 4]); medium-low (20% - < 50% breast milk [score = 5]); and low (<20% breast milk [score = 6]). In token breastfeeding, the breast is used primarily as a source of comfort for the infant, and breastfeeding is occasional and irregular, at <15 minutes a day (score = 7). The infant is considered weaned when no longer receiving any breast milk (score = 8).
Follow-up assessment will be take place when infants reached 1, 3, and 6 months corrected age. The research assistant will contact to the mother in advance then arrange the visit.
3. Data analysis
There will be six stages in data analysis. Stage 1: data preparation. Checking, editing and coding. Stage 2: data entry. Entering the data in the computer. Stage 3: Graphic presentation. Presenting the findings in the form of graphs or tables. Stage 4: data processing and analysis. Conducting statistical analysis. Stage 5: interpretation of the findings. Explaining the meaning of data individually. Stage 6: six- Conclusion. Proposing direct answers to the research question (Saratakos, 2005, p.364).
A t-test is an interval/ration test of significance which has the purpose of ascertaining whether or not the findings of a sample-based study are significant, that is also valid for the target population. It checks the degree if generalisability of the findings of the study. the t-test serves the same purpose as chi-square tests, except that it is suitable for interval/ration variables (Saratakos, 2005, p.388)
Analysis in this research will follow the intent to treat principle. SPSS computer software (version 15) will be used for data analysis. Differences between groups in demographic and other variables will be determined by using descriptive statistics, t-tests for interval level data, and Ï‡2 analysis (Fisher's exact test) for nominal data e.g. 1.baby gender, 2.birth weight, 3.gestational age, 4.maternal age, 5.education, 6.marital status, 7.race, 8.smoking history, 9.breastfeeding intention and 10.maternal employment (no, part-time, or full-time employment).
4. Probable outputs
If the result shows that skin-to-skin contact for full-term newborn babies during the first two hours postbirth has significant effect on first breastfeeding experience and also enhance the exclusive breastfeeding rate in six months postbirth.
The result will not only provide support in the Ten Steps to Successful Breastfeeding principle , especially in Step four recommends skin-to-skin contact in the early postnatal period, which should last until the first feed or for as long as the mother wishes but also increase its credibility in enhance breastfeeding establishment.
Early skin-to-skin contact can have a positive impact on newborn infants health by establish first breastfeeding well but also increase the mother's satisfaction as well as the bonding and interaction between mothers and newborn babies.
The skin-to-skin used to exercise as an intervention for premature babies, with the result, we can apply to generalisation. The intervention can not only use for premature babies but also works in healthy, full term babies. When apply the result into clinical practice, the newborn infant routine care in delivery will changed significantly. Firstly, in many healthcare setting, when delivery comes, the first priority is to dry the baby and keep the airway open and do a range of physical assessment and newborn routine care. Due the complicated tasks, mothers and newborn infants usually have to separate more than one hour which miss the most precious time for bonding between mothers and newborn infants. To implement the intervention, the old practice has to be changed. For clinical practitioners might need some time cope due to the various tasks and duties.
If the skin-to-skin contact intervention performs well in clinical practice, maybe researchers can put more effort in this area. For example, let the father or significant other practice the skin-to-skin contact with newborn infants and examine the effect might be operate as good as mothers.
5. Scheduling of the study
Identify data sources, archives and specialist library collections.Identify potential case studies.Review theory and methodology, policy and clinical practice.
Develop research question
Complete research proposal
Develop research methodology
Sampling and recruitment
Results, Data analysis and evaluation
Research project completed
6. Detailed justification of costs
¿¡/ per year
1. research assistant
2. clinical coordinator
¿¡9/ per hour
About 20 weeks
Attend conference, seminar, meeting
Fees and Service Charges
7. Ethical issues
There are some ethical issues we may meet when we do the research. Firstly, start with informed consent, in a research, participants should be fully informed as much information as possible that the participants can decide whether they want to join or not. Therefore , before we establish the research, all the participants will received oral and written information about the nature and purpose of the research study and its potential implications for them. After participants fully understood, inform consent will be obtained before we start the research. And participants also accept that they can stop or withdraw the research at any time they want. Secondly, the issue of the invasion of privacy, in the research project, Confidentiality and anonymous will be guaranteed. Any identification, documents will be separate from the tape recording and transcription. Data also will be stored in a locked and secure container, only the researcher can assess the key.
Last but not least, before any act, we have to obtain the approval from Research Ethics Committee. By doing so, everyone's right is protected.
8. Reflection on your study
Early skin-to-skin contact may not effect on first breastfeeding experience and breastfeeding duration, the reasons are vary. There are many factors influence breastfeeding negatively. For example, for working mother, maybe they experienced a very wonder first breastfeeding while having skin-to-skin contact with her baby when they in the hospital with healthcare provider's support and breastfeeding education. However, when the mother and her newborn infant go home, a range of unexpected things happened to them, without healthcare provider's help, short maternity leave and stressful work, all these reasons are affecting the decision of breastfeeding establishment and duration. Furthermore, if the intervention of skin-to-skin contact will implement in clinical practice, it will change the long established routine and roles which is difficult when face experience clinical practitioner whom don't like to change.
The following questions are from the Critical Appraisal Skill Programme (CASP, 2003). These 10 questions can help us think about these issues systematically.
1. Did the study ask a clearly-focused question?
In this research, the population, intervention and outcome are clearly stated.
2 .Was this a randomised controlled trial (RCT) and was it appropriately so?
In this research, I want to examine the effect of skin-to-skin contact for full-term newborn babies during the first two hours postbirth on first breastfeeding. To evaluate the effectiveness of skin-to-skin contact, I have to chose randomised controlled trial to test. In Glasziou's paper (2001), he stated that to study the effects of interventions, it is necessary to compare a group of patients who have received the intervention (study group) with a comparable group who have not received the intervention (control group). A randomized controlled trial, which is a trial in which subjects are randomly allocated to the study or control groups, is usually the ideal design.
3. Were participants appropriately allocated to intervention and control groups?
In the study, I will use computerized minimization to allocate participants, so I assume the participants will be allocated appropriately.
4. Were participants, staff and study personnel 'blind' to participants' study group?
In this study, participants, staff and study personnel, they won't blind to participant's study group, which could make observer bias and possibly a weakness in this study.
5. Were all of the participants who entered the trial accounted for at its conclusion?
In the study, I assume all the participants who entered the trial accounted for at its conclusion for avoiding attrition bias.
6. Were the participants in all groups followed up and data collected in the same way?
In the study, we have one research assistant dose the post-delivery care observation and assessment of first breastfeeding in the delivery room. And the other clinical co-ordinator responsible for documentation, so I presume the data will collected in the same way.
7. Did the study have enough participants to minimize the play of chance?
According to previous studies' effect size, in this study, we only recruit 15 participants
8. How are the results presented and what is the main result?
9 .How precise are these results?
10. Were all important outcomes considered so the results can be applied?
for question 8-10, it can not answered for the study is not carry out yet.
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