Ignite Creation Date:
2024-05-06 @ 6:47 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05780944
Status:
COMPLETED
Last Update Posted:
2023-03-23
First Post:
2023-02-28
Brief Title:
Short-term Effects of Paced Bottle-Feeding on Feeding Interactions
Sponsor:
California Polytechnic State University-San Luis Obispo
Organization:
California Polytechnic State University-San Luis Obispo
Study Overview
Official Title:
Does Paced Bottle-Feeding Improve the Quality and Outcome of Bottle-Feeding Interactions
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PBF
Brief Summary:
Current infant feeding recommendations focus on promoting responsive feeding which is widely recognized as the ideal way to feed infants because it is associated with healthier eating behaviors and growth outcomes for infants Unfortunately many bottle-feeding families receive inadequate support for learning responsive bottle-feeding practices because breastfeeding support is prioritized in healthcare settings Promotion of breastfeeding is an important focus for public health efforts but a significant proportion of families bottle-feed their infants either exclusively or in combination with breastfeeding Thus bottle-feeding remains a ubiquitous part of infant feeding and evidence-based strategies are needed to support bottle-feeding families One promising strategy is the Paced Bottle-Feeding PBF method which incorporates many ideas and feeding practices consistent with the concept of responsive feeding This approach to bottle-feeding aims to mimic the aspects of breastfeeding that promote balanced control between caregiver and infant and allow the infant to set the pace of the feeding in response to feelings of hunger and fullness Although PBF is sometimes taught in perinatal education settings teaching new parents about PBF is not an evidence-based practice because there have been no empirical studies evaluating the effectiveness of PBF for promoting responsive feeding for parents and healthy intake and weight outcomes for infants Thus despite the conceptual promise of PBF for promoting responsive bottle-feeding interactions research is needed to determine whether PBF is effective and identify whether any limitations of this method exist This study is a within-subject experimental study wherein mother-infant dyads will be observed during breastfeeding and typical bottle-feeding interactions Mothers will then be taught the PBF method and observed during a PBF interaction This design will allow for direct testing of the purported benefits of PBF over typical bottle-feeding and whether PBF makes the experience of bottle-feeding more equivalent to the experience of breastfeeding The overarching aims of this study are to explore the ways in which bottle-feeding can go well and identify mechanisms through which bottle-feeding families can be supported to promote healthy intake and weight gain trajectories for their infants
Detailed Description:
Infancy is a sensitive period for obesity prevention efforts in part because rapid weight gain during infancy is a stronger predictor of later obesity and metabolic comorbidities than weight gain trajectories during later life The first 6 months are of particular importance given research illustrating overfeeding during this early window places infants at significantly higher risk for rapid weight gain compared to overfeeding during later infancy To prevent overfeeding and rapid weight gain current recommendations and prevention programs primarily focus on promoting responsive feeding during infant feeding interactions
During responsive feeding infants are fed in ways that are developmentally appropriate and responsive to infant hunger and fullness cues Responsive feeding is widely recognized as the ideal way to feed infants because it gives them the scaffolded support to learn to recognize and eat in response to hunger and fullness cues and to self-regulate intake in response to physiological needs Indeed responsive feeding is associated with healthier eating behaviors and growth outcomes for infants
Promotion of responsive feeding is typically a core component of breastfeeding promotion and education However a significant proportion of families bottle-feed their infants either exclusively or in combination with breastfeeding US data illustrate 42 of infants are exclusively bottle-fed by 6 months of age and 70 of breastfed infants receive supplemental formula or bottle-feedings on a regular basis Thus bottle-feeding is a ubiquitous part of infant feeding and evidence-based strategies are needed to complement breastfeeding education and promote responsive bottle-feeding
Unfortunately many bottle-feeding families receive inadequate support for learning responsive bottle-feeding likely because breastfeeding support is prioritized in health care settings In addition mothers perceive health professionals to be ill-prepared to help them with their formula- and bottle-feeding needs and reluctant to discuss formula- or bottle-feeding at the risk of compromising breastfeeding support A striking 1 in 5 formula-feeding mothers reported they received no advice related to infant feeding from health care professionals compared to only 5 of breastfeeding mothers
To date few studies address this need creating a significant research gap that hinders support for bottle-feeding families Thus promotion of responsive bottle-feeding remains a realistic but under-utilized facet of early support One promising strategy is the paced-bottle feeding PBF method which incorporates many concepts and strategies consistent with the concept of responsive feeding
PBF was first introduced by a lactation consultant to reduce nipple confusion and bottle-preference among breastfeeding infants being introduced to bottles In brief to implement PBF caregivers are taught to
Initiate feeding when the infant shows hunger cues eg rooting sucking noises
Hold the infant during the entire feeding and avoid propping the bottle on a blanket or leaving the feeding infant unattended
Hold the bottle horizontal so that the nipple is only partially full of milk and hold the infant upright instead of a more prone position to moderate milk flow and encourage the infant to actively work to remove milk
When offering the bottle allow the infant to take the nipple rather than pushing or forcing the nipple into the infants mouth
Allow the infant to pause and take breaks
Switch the infant from one side to the other during the feeding just like a mother would switch breasts
Allow at least 15-20 minutes for feeding so the infant has enough time to feel full
Terminate feeding when the infant exhibits fullness cues eg slowing pace of feeding turning away refrain from encouraging the infant to finish the bottle
The purported but untested benefits of PBF stem from the idea that PBF makes the experience of bottle-feeding more equivalent to the experience of breastfeeding by slowing the pace of feeding and increasing the amount of effort infants expend during bottle-feeding Proponents of PBF claim that these features of PBF promote balanced control between caregiver and infant wherein the infant is better able to set the pace of feeding and stop feeding when full reducing risk for spitting up and overfeeding
Since its introduction in 2002 education about PBF during prenatal breastfeeding classes has grown in popularity Additionally the Special Supplemental Nutrition Program for Women Infants and Children WIC began to incorporate PBF into their infant feeding education curriculum for both breast- and formula-feeding mothers Although promising teaching new parents PBF is not an evidence-based practice because there have been no empirical studies evaluating the effectiveness of PBF for promoting responsive feeding and healthy intake and weight outcomes for infants Thus despite the conceptual promise of PBF for promoting responsive bottle-feeding research is needed to determine whether PBF is effective and observe whether any limitations of the method exist
The objective of this project will be to address this research gap by comparing short-term feeding interactions and outcomes during PBF to both breastfeeding and typical bottle-feeding This study is a within-subject experimental study of 60 mother-infant dyads who are both breast- and bottle-feeding Within this study mothers will be observed during breastfeeding and typical bottle-feeding interactions Mothers will then be taught the PBF method and observed during a PBF interaction
This study will address the following specific aims
Aim 1 To test the hypothesis that PBF will lead to significantly lower infant milk intake mL longer meal duration min slower rate of feeding mLmin and lower frequency of spitting up compared to typical bottle-feeding but similar intake meal duration rate of feeding and frequency spitting up compared to breastfeeding
Aim 2 To test the hypothesis that mothers will exhibit greater sensitivity and responsiveness to infant cues during PBF compared to typical bottle-feeding but similar sensitivity and responsiveness to infant cues compared to breastfeeding
Aim 3 To test the hypothesis that infants will exhibit greater clarity of cues and responsiveness to feeding during PBF compared to typical bottle-feeding but similar clarity of cues and responsiveness to feeding compared to breastfeeding
During responsive feeding infants are fed in ways that are developmentally appropriate and responsive to infant hunger and fullness cues Responsive feeding is widely recognized as the ideal way to feed infants because it gives them the scaffolded support to learn to recognize and eat in response to hunger and fullness cues and to self-regulate intake in response to physiological needs Indeed responsive feeding is associated with healthier eating behaviors and growth outcomes for infants
Promotion of responsive feeding is typically a core component of breastfeeding promotion and education However a significant proportion of families bottle-feed their infants either exclusively or in combination with breastfeeding US data illustrate 42 of infants are exclusively bottle-fed by 6 months of age and 70 of breastfed infants receive supplemental formula or bottle-feedings on a regular basis Thus bottle-feeding is a ubiquitous part of infant feeding and evidence-based strategies are needed to complement breastfeeding education and promote responsive bottle-feeding
Unfortunately many bottle-feeding families receive inadequate support for learning responsive bottle-feeding likely because breastfeeding support is prioritized in health care settings In addition mothers perceive health professionals to be ill-prepared to help them with their formula- and bottle-feeding needs and reluctant to discuss formula- or bottle-feeding at the risk of compromising breastfeeding support A striking 1 in 5 formula-feeding mothers reported they received no advice related to infant feeding from health care professionals compared to only 5 of breastfeeding mothers
To date few studies address this need creating a significant research gap that hinders support for bottle-feeding families Thus promotion of responsive bottle-feeding remains a realistic but under-utilized facet of early support One promising strategy is the paced-bottle feeding PBF method which incorporates many concepts and strategies consistent with the concept of responsive feeding
PBF was first introduced by a lactation consultant to reduce nipple confusion and bottle-preference among breastfeeding infants being introduced to bottles In brief to implement PBF caregivers are taught to
Initiate feeding when the infant shows hunger cues eg rooting sucking noises
Hold the infant during the entire feeding and avoid propping the bottle on a blanket or leaving the feeding infant unattended
Hold the bottle horizontal so that the nipple is only partially full of milk and hold the infant upright instead of a more prone position to moderate milk flow and encourage the infant to actively work to remove milk
When offering the bottle allow the infant to take the nipple rather than pushing or forcing the nipple into the infants mouth
Allow the infant to pause and take breaks
Switch the infant from one side to the other during the feeding just like a mother would switch breasts
Allow at least 15-20 minutes for feeding so the infant has enough time to feel full
Terminate feeding when the infant exhibits fullness cues eg slowing pace of feeding turning away refrain from encouraging the infant to finish the bottle
The purported but untested benefits of PBF stem from the idea that PBF makes the experience of bottle-feeding more equivalent to the experience of breastfeeding by slowing the pace of feeding and increasing the amount of effort infants expend during bottle-feeding Proponents of PBF claim that these features of PBF promote balanced control between caregiver and infant wherein the infant is better able to set the pace of feeding and stop feeding when full reducing risk for spitting up and overfeeding
Since its introduction in 2002 education about PBF during prenatal breastfeeding classes has grown in popularity Additionally the Special Supplemental Nutrition Program for Women Infants and Children WIC began to incorporate PBF into their infant feeding education curriculum for both breast- and formula-feeding mothers Although promising teaching new parents PBF is not an evidence-based practice because there have been no empirical studies evaluating the effectiveness of PBF for promoting responsive feeding and healthy intake and weight outcomes for infants Thus despite the conceptual promise of PBF for promoting responsive bottle-feeding research is needed to determine whether PBF is effective and observe whether any limitations of the method exist
The objective of this project will be to address this research gap by comparing short-term feeding interactions and outcomes during PBF to both breastfeeding and typical bottle-feeding This study is a within-subject experimental study of 60 mother-infant dyads who are both breast- and bottle-feeding Within this study mothers will be observed during breastfeeding and typical bottle-feeding interactions Mothers will then be taught the PBF method and observed during a PBF interaction
This study will address the following specific aims
Aim 1 To test the hypothesis that PBF will lead to significantly lower infant milk intake mL longer meal duration min slower rate of feeding mLmin and lower frequency of spitting up compared to typical bottle-feeding but similar intake meal duration rate of feeding and frequency spitting up compared to breastfeeding
Aim 2 To test the hypothesis that mothers will exhibit greater sensitivity and responsiveness to infant cues during PBF compared to typical bottle-feeding but similar sensitivity and responsiveness to infant cues compared to breastfeeding
Aim 3 To test the hypothesis that infants will exhibit greater clarity of cues and responsiveness to feeding during PBF compared to typical bottle-feeding but similar clarity of cues and responsiveness to feeding compared to breastfeeding
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None