Breastfeeding Support Intervention in Jaundiced Infants
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|ClinicalTrials.gov Identifier: NCT00966719|
Recruitment Status : Completed
First Posted : August 27, 2009
Results First Posted : March 28, 2019
Last Update Posted : April 17, 2019
|First Submitted Date ICMJE||August 26, 2009|
|First Posted Date ICMJE||August 27, 2009|
|Results First Submitted Date ICMJE||April 26, 2018|
|Results First Posted Date ICMJE||March 28, 2019|
|Last Update Posted Date||April 17, 2019|
|Study Start Date ICMJE||October 2009|
|Actual Primary Completion Date||January 2013 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||Number of Participants Exclusively Breastfeeding at 3 Months, or 3 Months Corrected if the Infant Was Born Prematurely [ Time Frame: 3 months ]
Exclusive breastfeeding was defined as no milk intake other than breast milk
|Original Primary Outcome Measures ICMJE
||Exclusive breastfeeding at 3 months, or 3 months corrected if the infant was born prematurely. [ Time Frame: 3 months ]|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||Breastfeeding Support Intervention in Jaundiced Infants|
|Official Title ICMJE||The Impact of a Breastfeeding Support Intervention on Breastfeeding Duration in Jaundiced Infants Admitted to a Tertiary Care Centre: a Randomized Controlled Trial.|
Breastfeeding decreases the risk of many infantile infectious diseases and certain types of cancers in women. It strengthens the bond between mothers and babies and decreases the health care cost to society by making children healthier. Although it is controversial, breastfeeding has been reported to increase the risk of jaundice in the neonatal period. There is some evidence that mothers of hospitalized jaundiced infants discontinue breastfeeding early, as they feel responsible for the baby's condition.
The main objective of this study is to determine the effect of a breastfeeding intervention on breastfeeding duration in jaundiced infants. All eligible infants will be randomized to one of two groups (an intervention or a control group). Mothers of infants in the intervention group will meet with a lactation consultant during their hospital stay, and three times post hospital discharge. Lactation consultants are individuals who have received certification in breastfeeding support from an international board, ensuring safe and effective practice. Mothers of infants in the control group will receive the current standard of care, which is typically support from the nursing staff, who are often not trained in lactation support. Information will be collected on length of time that infants are fed only breast milk, future visits to health care providers, mothers' need for breastfeeding support post hospital discharge, mothers' perception of their physicians' attitudes towards breastfeeding, and mothers' experiences at the hospital, as well as feedback on the intervention. Phone follow-up will occur one week post hospital discharge, and when the child is 2, 3, 4 and 6 months old.
The results of this study will clarify the importance of offering sound breastfeeding advice to mothers of young infants hospitalized with jaundice and help determine whether there is a need for trained lactation specialists in children's hospitals. It will allow us to examine whether such an intervention can have a quantifiable impact on children's health in their first 6 months of life, as measured by physician encounters and hospitalizations. It will also allow collection of information on advice and support given to breastfeeding women by primary care physicians, potentially identifying needs for more rigorous breastfeeding training during medical training.
1.1 Overview This study will assess the effectiveness of a breastfeeding support intervention for infants admitted to the hospital with jaundice. It will evaluate the effect of this intervention on duration of breastfeeding and health care utilization.
1.2 Study Objectives: Primary: To determine the effect of a breastfeeding support intervention on breastfeeding duration in breastfeeding infants admitted to the hospital with jaundice.
2.1 Summary: Breastfeeding confers many advantages to infants, mothers, families, and society in general. There is strong evidence that human milk feeding decreases the incidence of many infectious diseases and enhances the immunologic status of the newborn. It has been associated with enhanced performance on neurocognitive development tests, and has also been shown to provide important health benefits to the mother, including a decrease in risk of breast and ovarian cancers. It should be strongly encouraged for the first six months of life, and then continued for up to 2 years and beyond, as recommended in the World Health Organization's Innocent Declaration.
Neonatal jaundice is the most common problem in full-term infants during the immediate post-natal period. There is controversy as to whether breastfeeding increases the incidence of jaundice in the first days of life. In a study conducted in Italy, neonatal jaundice was not associated with breastfeeding per se, but rather with increased weight loss after birth subsequent to fasting, which can be seen with inadequate lactation.
When an infant is hospitalized, previously established patterns of breastfeeding are difficult to maintain. There is evidence to suggest that mothers of young infants admitted to hospital with hyperbilirubinemia commonly experience guilt as they feel breastfeeding caused the jaundice. Many of these women struggle with feelings of failure or inadequacy. A study recently conducted by the principal investigator of this current study (CP) suggested that infants admitted to the hospital with hyperbilirubinemia may have a higher rate of breastfeeding discontinuation than babies in the general population.
Previous studies have shown that breastfeeding support offered to various groups of mother-infant pairs significantly increased rates of breastfeeding at 2 to 6 months of age.
Given the clear health, social and economic advantages that breastfeeding confers to mothers, infants, and society in general, there is a need to assess the effectiveness of a breastfeeding support intervention for infants admitted to the hospital with jaundice.
2.2 Benefits of breastfeeding Breastfeeding is preferred for all infants, and exclusive breastfeeding of infants is recommended for the first 6 months after birth. Research has shown that human milk feeding decreases the incidence of multiple illnesses including bacterial meningitis, bacteremia, diarrhea, respiratory tract infection, otitis media, and urinary tract infections. A recent study conducted in Spain showed that exclusive breastfeeding lowered the risk of hospitalization as a result of infectious diseases during the first year of life. In that study, each additional month of exclusive breastfeeding would have avoided 30% of hospital admissions. A meta-analysis of 33 studies examining healthy infants in developed nations showed similar results, with formula-fed infants experiencing a tripling in severe respiratory illnesses compared with those who were exclusively breastfed for 4 months. Based on these results, breastfeeding promotion can lead to important economical gains from a societal perspective.
According to the most recent Ottawa Public Health Survey, breastfeeding rates in the general population are as follows: 91% of women initiate breastfeeding, with 56% practicing exclusive breastfeeding (no fluids other than breast milk). At 3 months, 71% of women continue to breastfeed, with 50% doing exclusive breastfeeding. This number drops to 60% for any breastfeeding at 6 months, with 39% of women exclusively breastfeeding.
2.3 Breastfeeding in hospitalized children Published reports have shown that previously established patterns of breastfeeding are hard to maintain once an infant is hospitalized. Moreover, as mentioned, evidence suggests that mothers of infants admitted to the hospital with jaundice experience guilt, as well feelings of failure and inadequacy as they often feel responsible for the child's admission to hospital. Maternal confidence has been shown to be a strong predictor of breastfeeding duration, with lack of confidence in breastfeeding skills leading to a higher likelihood of weaning in the first six weeks post-partum. There is only one study in the literature examining the rates of breastfeeding in the jaundiced population, which was done by the PI of this current study. Surveys were sent to all mothers of eligible infants admitted with jaundice to the Children's Hospital of Eastern Ontario (CHEO) over a 2.5 year period. One hundred and twenty-eight (64%) out of the 200 eligible mothers returned a completed survey. Of those, 92% had a post-secondary education. Information was collected, retrospectively, on length of breastfeeding after discharge from the hospital. Length of breastfeeding for hospitalized infants was compared to that of the Ottawa population, as reported by the City of Ottawa Public Health survey in 2005. Although numbers were the same between the jaundiced group and the City of Ottawa group, it is likely that the high education level of the study participants falsely elevated the rate of breastfeeding in the jaundiced infants. As mentioned, 92% of study participants had completed a post-secondary education, as compared to 53% of women involved in the population-based survey. Given that previous reports have shown that women with lower levels of education are more likely to discontinue breastfeeding early, it is reasonable to postulate that for comparable levels of education, mothers of infants admitted to the hospital with jaundice discontinue breastfeeding earlier than women in the general population.
2.4 Breastfeeding support interventions There are very few studies quantifying the effects of breastfeeding promotion interventions. A recent Cochrane review found that both professional and lay support were effective in prolonging breastfeeding. More specifically, this review found that professional support had more of an impact than lay support on both partial and exclusive breastfeeding and lay support affected exclusive breastfeeding. A review of four randomized controlled trials combining breastfeeding support with educational programs in developed countries found that combined education and support strategies increased short-term breastfeeding rates by 36%. Short-term breastfeeding in these studies was described as anywhere between 2 to 6 months. The education interventions were primarily conducted by lactation specialists or nurses as antepartum sessions, while the support interventions varied between telephone or in-person conversations, hospital or home visits by lactation consultants, nurses or peer counselors, and combined prearranged appointments and unscheduled visits or telephone calls for problems. Breastfeeding education and support had the biggest effect on initiation and maintenance of breastfeeding. Many of the studies however lacked scientific rigor. Most studies did not make a difference between exclusive and partial breastfeeding. Details regarding description and length of interventions as well as training of the individual delivering the educational session were often lacking.
A recent randomized controlled trial evaluating the effectiveness of a breastfeeding promotion intervention in the Republic of Belarus19 found an absolute increase of almost 37% in the prevalence of exclusive breastfeeding at 3 months in the intervention group. The chief obstetrician from each intervention maternity hospital, and the chief pediatrician from each intervention polyclinic, received the same 18-hour courses emphasizing methods to maintain lactation, promote exclusive and prolonged breastfeeding, and resolve common problems. All midwives, nurses and physicians providing care to study mothers and infants, as well as all pediatricians and nurses working in the polyclinics were trained over a period of 12 to 16 months. Such a program offered the advantage of providing reliable and consistent support, with the goal of being widely available. This study was published after the Cochrane review and thus is not included in the review.
Although no study published to date has determined which aspect of a breastfeeding support intervention yields positive results, it is likely to result from a combination of factors. Breastfeeding support results in increased confidence, and maternal confidence is known to be a strong predictor of breastfeeding outcome, with lack of confidence in breastfeeding skills leading to a higher likelihood of weaning in the first six weeks post-partum.
2.5 Availability of breastfeeding support In the recent CHEO study, 57% of the participating mothers needed to seek breastfeeding support after discharge from the hospital, suggesting they did not receive adequate help while hospitalized. Half of these women received help from private lactation consultants. These lactation consultants have variable training and may or may not hold recognized certifications or credentials. Their fees also vary from 10$ to 90$ an hour, and therefore may not be a suitable alternative for families with financial difficulties. This indicates the need for a standardized breastfeeding support intervention that will be accessible to all.
2.6 Breastfeeding and health care professionals Many studies have shown that physicians and physicians in training lack the necessary skills to offer proper guidance to lactating mothers. Freed et al surveyed pediatric residents and practitioners about breastfeeding knowledge and found that both groups had considerable knowledge deficits, and were ill-prepared for counseling mothers with lactation difficulties. Many residents surveyed in a study performed by Hillenbrand et al believed that early supplementation was not a cause of breast-feeding failure, although previous studies have clearly demonstrated this relationship. In the Ottawa study, only 3.9% of women reported receiving breastfeeding help from the treating physician while admitted to the hospital, suggesting the possibility that physicians do not have adequate knowledge to assess proper breastfeeding methods and counsel appropriately.
In summary, there is a need for this comprehensive study examining the impact of a breastfeeding support intervention for mothers of infants admitted to the hospital with jaundice. This study will clarify the rates of early breastfeeding discontinuation in the jaundiced population and help determine whether physicians in the Ottawa population have knowledge deficits when it comes to breastfeeding, as there may be a role for incorporating teaching of breastfeeding skills to physicians and physicians in training.
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
|Intervention ICMJE||Other: Lactation Consultant support
Meeting with lactation consultant once while in hospital and up to 3 times after discharge, in addition to current standard of care for jaundice.
Other Name: Breastfeeding support
|Study Arms ICMJE||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Actual Enrollment ICMJE
|Original Estimated Enrollment ICMJE
|Actual Study Completion Date ICMJE||April 2013|
|Actual Primary Completion Date||January 2013 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages ICMJE||up to 1 Month (Child)|
|Accepts Healthy Volunteers ICMJE||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Canada|
|Removed Location Countries|
|NCT Number ICMJE||NCT00966719|
|Other Study ID Numbers ICMJE||09/23E|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement ICMJE||Not Provided|
|Responsible Party||Catherine Pound, Children's Hospital of Eastern Ontario|
|Study Sponsor ICMJE||Children's Hospital of Eastern Ontario|
|Collaborators ICMJE||The Physicians' Services Incorporated Foundation|
|PRS Account||Children's Hospital of Eastern Ontario|
|Verification Date||April 2019|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP